Philips Announces 8 year warranty on Heartstart Onsite and FRx AED's

Philips Healthcare has recently announced that all Philips Heartstart Onsite and FRx AED's sold after 12-1-2012 will now come with an 8 year manufactures warranty. Shop for Philips AED's today!

AED's Save Lives in Schools

With an increasing number of students at local schools having cardiac episodes, the public is becoming more aware of what we have always known, children and young adults can and do have cardiac arrest. It is estimated that as many as 1 in 500 children have undiagnosed heart conditions, and approximately one case of sudden cardiac death occurs every three days in organized youth sports across the United States. This alarming statistic has teachers and parents on edge. “It seems that we lose at least one child locally per year due to cardiac arrest” says Jason Royse, President of Northwest Health and Safety Inc. “That number is unacceptable and there is something that we can and should be doing about it”.
Heart screening in young athletes is a priority and should be a part of every sports physical. States need to recognize that this is a public safety issue and develop strategies to make these screenings affordable and commonplace. Organizations like the Quinn Driscoll Foundation have partnered with Peace Health Southwest Medical Center to provide heart screenings for young athletes in the Clark County area at a significant discount. These screenings include a review of child’s personal and family health history, blood pressure, ECG/EKG (electrocardiogram) and echocardiogram (ultrasound of the heart).  The screenings have been proven effective and have identified cardiac conditions that have allowed young athletes the ability to seek treatment.
Training staff in CPR and use of the AED should also be a standard by all schools and districts. When cardiac arrest strikes, the clock is ticking and survival depends on early CPR and early defibrillation. You cannot depend on a fast arriving EMS unit to provide treatment. Although you will call EMS immediately, the typical EMS response time in the United States is 8-10 minutes. What do you do while you wait? You start providing care with CPR and an AED (if one is available). Some studies show that the chances of survival decrease about 10% every minute without a defibrillator. CPR is easy to learn and can mean the difference between life and death.
Implementing an AED program within each school. AED’s in schools are becoming commonplace. Many states have passed legislation requiring AED’s in schools. It is important to not just place an AED but place an AED program, there is a difference. Placing an AED in a school means nothing if there is not a plan in place for training, maintenance, placement, medical direction and other key factors addressed. AED’s save lives not just for children but adults as well. Watch this news story of a young lady that was saved with an AED.
To find out more information about any of the subjects listed click on a link:
Quinn Driscoll Foundation
Young Champions Heart Screening
AED’s in Schools
AED laws
CPR Training

Oregon Requires AED's in Schools

The state of Oregon passed legislation that will require all schools in the state to install and maintain at least one Automated External Defibrillator. Oregon SB 1033 Relating to automated external defibrillators in schools; creating new provisions; and amending ORS431.680 and 431.690. Compliance is required on or before January 1, 2015. The legislation applies to all schools: public, private and charter schools. Northwest Health and Safety Inc is a leading provider of AED programs and implementation programs for schools in Oregon and Washington. We have successfully implemented hundreds of AED programs within schools and understand the complexities of school AED implementations. The Oregon Department of Education has provided some information, guidance and sample policies for school districts and schools.

AED Programs

Northwest Health and Safety Inc. is a leading and most experienced provider of Automated External Defibrillators (AED’s) and specializes in implementing AED programs for business, schools, golf courses, churches, non-profit organizations and industrial settings. Our AED experts can assist you with every aspect of your AED program from:

• Budgeting
• Device Selection
• Program Design
• Medical Direction/Physician Oversight
• EMS Integration/Notification
• Policies and Procedures
• Maintenance
• Installation
• CPR/AED Training
• Loaner programs
• Risk Management
• Ongoing Support
• Expiration Reminders

There is more to setting up an AED program than just going out and purchasing an AED. There are state requirements that dictate AED placement standards and minimum requirements. Most states have 4 main requirements for AED placement in public places: CPR and AED Training, Medical Direction/Oversight, EMS notification and Maintenance in accordance with manufacture specifications (monthly inspections).
Northwest Health and Safety Inc. has successfully implemented thousands of successful AED programs within schools, churches, government buildings, businesses, golf courses, health clubs, childcare facilities and much more. We have over 13 years of experience working with AED’s and feature all the major AED brands from Cardiac Science, Defibtech, Heartsine, Physio-Control, Philips and ZOLL. For more information on AED’s visit us at AEDUniverse.com or AED4U.com. There is only one choice for implementing your AED programs in the Northwest. Northwest Health and Safety Inc. stocks replacement AED pads and batteries for all major AED brands at their Vancouver, Washington store.

Northwest Health and Safety Inc. is an Authorized AED Distributor serving Washington, Oregon and Idaho and nationwide. for more information on AED’s and AED programs visit our AED site AEDUniverse.com 

Oregon Passes Legislation Requiring AED's in Schools

During the 2010 Special Session, the Legislature passed Senate Bill 1033.  This bill requires each school campus to have at least one automated external defibrillator (AED) on premises. Compliance is required on or before January 1, 2015. The new Oregon AED law applies to all public schools, private and charter schools in the state of Oregon. 


Northwest Health and Safety Inc is a leading provider of AED's and AED programs to schools and businesses. We have established hundreds of school based AED programs from AED planning, AED Selection, Placement, Policies and Procedures, EMS integration, Training, Medical Direction and Oversight. Northwest Health and Safety Inc. has the resources and understanding of AED programs to make sure your school has all the information to put together a successful and affordable AED program. We work with all the leading AED manufactures from Cardiac Science, ZOLL, Defibtech, Physio-Control, Philips and Heartsine. We have special discount pricing and programs for Oregon schools affected by the new AED requirement. Have questions about AED's? Just call and we'll be happy to assist you. 1-866-517-8243 or visit us online at AEDUniverse.com or AED4U.com

Why Put AED's Schools? One question we receive quite frequently is: Why do we need AED's in schools? Although the incidence of cardiac arrest is higher in adults than children, there is a vast amount of information that suggests cardiac arrest in children is on the rise and just one incident can devastate a school and a community. Schools are not just for children, schools are for the community and tend to be a gathering place for public functions and events and are frequented by all ages. We have complied some articles about AED's in schools and cardiac arrest in children. AEDUniverse.com and Northwest Health and Safety Inc. has partnered with schools across the country to provide selected AED's and Accessories to schools at discounted prices. Are you a school? Call AEDUniverse.com at 1-866-517-8243 to learn more about our school discounts and school AED packages. Resources Legal Prospective of AED's in Schools Sample AED School Policy

AEDUniverse.com and Northwest Health and Safety Inc. is committed to assisting schools in implementing AED programs. We are experienced and have assisted hundreds of schools and school districts in properly implementing successful AED programs. We can assist schools in site selection, training, policies and procedures, AED maintainence procedures and EMS notification/integration. 

2011 is here. Now go check your AED!

With the new year here it is a great to time go thru your AED plan and check your AED for readiness. Check the expiration date of your AED pads, Check the status indicators, check batteries and make sure responders are trained in new guidelines of CPR and AED. Having a properly maintained AED is important step in assuring overall readiness. AEDUniverse.com has a vast amount of information on checking your AED and other AED resources to help you with this process.

Northwest Health and Safety Inc. takes over Safety Services Networks and Advantage Procurement

Northwest Health and Safety Inc. has made agreements with Safety Services Network and Advantage Procurement to take over AED operations for the ZOLL, Philips, Defibtech and Heartsine AED's previously sold and serviced by Safety Services Network and Advantage Procurement. Customers who have purchased the ZOLL AED, Philips AED or Heartsine AED's from Safety Services Network and Advantage Procurement should contact Northwest Health and Safety Inc. for any issues related to their AED or for warranty assistance at 1-866-517-8243. 

Northwest Health and Safety Inc. has recently acquired We are excited to offer our customers a full range of AED's and AED accessories at low prices. For more information on AED's visit aed4u.com or can also visit our newest AED Website www.aeduniverse.com

Setting up a successful AED program

One question we get frequently is customers that want to start an AED program but don't know just quite where to start. AEDUniverse.com has complied some information on how best to implement that AED program:

Setting up a successful AED program


Determine Need

The first step in establishing an AED program is to determine that you need one to begin with. The second step is proving it to the bosses. Studies indicate that in the US alone there are over 450,000 deaths per year due to Cardiac Arrest. Cardiac Arrest kills more people than car accidents, breast cancer, prostate cancer, handguns, fires, and AIDS COMBINED with a majority of cardiac arrests occurring outside the hospital. The death of one employee, friend, co-worker or family member can devastate a workplace or public setting. As the public becomes more aware of AED's and their importance in saving lives, the expectation of providing adequate care by someone trained in CPR and an AED nearby is going to become the standard. It is important to understand as you decide to move forward in your AED decision that setting up an AED is not just going online and buying an AED, it is a commitment by everyone involved to build a solid foundation for an AED program that will be successful long term.

Identify a champion

It is important to identify someone within your organization that will take the lead in building the AED program. This person should be committed to the long term success of the program, gather information, act as the AED liaison and the facilities AED expert. The champion will perform the research on AED's and meet with stakeholders to determine budget, policies, who will be trained, maintenance procedures and logistics.

Research and Understand State and Jurisdictional AED Requirements

You should understand all the requirements for your state when placing an AED. Don't worry its not as difficult as you think and we'll help you out along the way. Check out our AED laws by state page to determine what your laws or requirements are for placing an AED in your facility. Most state laws have the same basic 3-4 requirements for placing an AED in a public setting. 1. Medical Direction 2. EMS Notification 3. Maintenance in accordance with manufactures specifications 4. Training in CPR & AED. We will discuss these specific components in detail. In addition there maybe state registration requirements.

Medical Direction

What is medical direction and why do I need it?

Many states require that AED programs to have Physician Oversight or Medical Direction as a part of their overall AED plan. Medical Directors typically review policies and procedures, assure adequate training has been provided to rescuers, consult on placement and are available for program guidance and event review. You may already work with a physician that can oversee your program and serve as a medical director. It is important to review your individual state laws to determine if Medical Direction is required. Many states are starting to repeal this requirement.

What if I don’t have a Medical Director?

Ideally you can find a local physician that will work with you and act as your medical director but if not, we work with ENPRO an AED program management solution that can provide you with a full program to assure regulatory compliance regardless of your location. ENPRO can provide your organization with Medical Direction, Policies and Procedures, PlusTrac (AED inspection reminder Service with documentation), EMS notification, AED training programs (additional fee), regulatory tracking, upgrade/correction notifications. Click here for more information

What is the difference between Prescription/Medical Authorization and Medical Direction?

AED’s are regulated as class III medical devices and do require a prescription for purchase(the Philips Heartstart Onsite is available without a prescription) All AED purchases thru AEDUniverse.com come with a Prescription and Medical Authorization. The Prescription/Medical Authorization only facilitates purchase and fulfills FDA requirements. Medical Direction is a Physician overseeing the AED program and reviews AED events. Medical Direction is not include with your AED purchase and you may need to purchase separately depending on your state.

EMS Notification

Many states require EMS notification as a requirement for placing an AED. This allows the servicing or responding agency to know that an AED is at a particular location and in some instances the 911 dispatcher will have that information and can advise callers to its location. To meet the requirement you will need to first determine who you need to send the notification to. Most laws just say "notification to servicing EMS agency" talk with your local fire department and they maybe able to help you determine where the notification needs to go. Some states require state registration. Your states Health Department can also be helpful in answering your questions. Once you have determined who you need to notify, we suggest sending the EMS notification via certified mail.

Sample EMS Notification Letter
Check with you State Health Department or EMS agency to determine your states specific requirements.

Visit our AED Laws by State Page for your AED laws.

AED Maintenance

Most state AED laws require that AED's be maintained in accordance with manufacture specifications. How do you do that? We have compiled excerpts from each specific AED's operations manuals that explains the operational tests and checks that should be done on a regular basis. Some even have checklist that you can just print out!
Click to find out what you need to do to check your AED

Cardiac Science

Powerheart G3 Plus Maintenance Procedures

Defibtech

Lifeline & Reviver Maintenance Checklist

Heartsine

Heartsine Maintenance Checklist

Philips

Philips Onsite Maintenance Procedures
Philips FRX Maintenance Procedures

Physio-Control

CR Plus & Express Maintenance Checklist
LIFEPAK 1000 Maintenance Checklist
LIFEPAK 500 Maintenance Checklist

ZOLL
ZOLL AED Plus Maintenance Checklist

How to test and inspect your ZOLL AED Plus - Video

AED Inspection tags are a great tool to record the AED monthly inspections. Do it at the same time you do your fire extinguisher inspections.

CPR and AED Training

CPR and AED Training is criticial to your AED programs success. One thing we hear often is "why do we need to be trained on the AED, isn't it really easy to use?" While it is true AED's are very easy to use, it is only half the battle. During cardiac arrest Defibrillation is indicated about 60% to 70% of the time, however CPR is indicated 100% of the time and with the combination of early CPR and early defibrillation you can increase the persons chance of survival significantly. It is important to budget CPR/AED training when planning your AED program. Most states require training in order to be covered with civil immunity for using a defibrillator. Good CPR and AED training will typically last 3-4 hours and cost between $30-$50 per person. Refresher training should be every 2 years at a minimum. Some states stipulate the AED programs that are approved for AED training.
When finding a instructor to provide your training it is important to find an experienced instructor who knows and understands AED's. Ask the instructor if he has a training AED, perhaps the same model you are purchasing? People can be apprehensive about being a part of the response team or being a trained responder but by having good quality training and lots of hands on can help out tremendously.
Find out what your state requires and visit our AED state laws page.


Training Videos

*Physio Control CR Plus and Express Training Videos

*Note: Training videos should not take the place of traditional CPR and AED training, but rather serve as a refresher between formal CPR and AED Training Classes

Need training in Washington or Oregon? We provide training services in Washington State and Oregon.
Visit nwcprtraining.com for more details.

AED Policies and Procedures

A good AED program will have policies and procedures that outline the AED program criteria, responsibility of rescuers, maintenance guidelines, operational steps for use, post event procedures, reporting mechanisms and will be your overall guide that outlines the AED program as a whole. Typically the policies and procedures will be created with the input of all stake holders (HR, Security, Legal and Management). We have some sample policies and procedures from schools and business. Keep in mind that every AED placement and situation is going to be a little different and if you do decide to use our policy templates make sure that you modify to meet your needs and your state requirements.

*Sample AED Policies and Procedures
*Sample AED Policies and Procedures 2
*Sample School Policies and Procedures

*The sample AED policies are intended as an example and is not intended as medical or legal advice. Permission is granted to reproduce these sample AED policies for the purpose of using it as a starting point towards the creation of a formal AED policy. Before preparing and implementing any AED policy, ensure that it fully complies with the directions of your medical advisor, applicable laws, regulations, corporate policies and manufacturer's operating procedures. AEDUniverse.com makes no warranties as to the accuracy and completeness of the samples provided.

Legal Risk

Is there increased legal risk to me or my organization for implementing an AED program?

All organizations should evaluate the relative risks and benefits when considering the implementation of any program that affects employee welfare. According to the American Heart Association, to date, no known judgments have been rendered against the operator of an AED for negligent or improper use of AEDs. According to an article on AEDs and legal liability published in Air & Space Lawyer (a publication of the American Bar Association), “liability claims associated with the negligent operation of AEDs are mitigated by the difficulty in establishing that the operator proximately caused harm to the victim…The AED operator is attempting to resuscitate an individual who, absent the AED, will likely remain dead.”

By contrast, recent news indicates that corporations may face liability for failing to have an AED available to treat a victim of sudden cardiac arrest. For example, in June 1996, a Florida jury found Busch Gardens negligent for not properly training its employees to provide emergency care and for failing to have essential medical equipment, including a defibrillator, on the premises. The plaintiff was awarded $500,000 in damages for the death of her teenage daughter at the amusement park. This is just one example of many judgments that have been handed down since then as a result of not having AED's and properly trained individuals available in an emergency.

The Cardiac Arrest Survival Act passed by Congress in 2000 provides a model that states could adopt to encourage widespread use of AEDs and other lifesaving devices and provide immunity for those who give emergency care. Read the Cardiac Arrest Survival Act. Good Samaritan laws enacted by nearly every state enable a range of non-traditional emergency responders to use AEDs. In further support of these legislative efforts, Many AED manufactures offer customers an indemnification agreement to AED users in the event of product malfunction* (terms vary by manufacture).

In summary, the benefits of AEDs, the relative manageable cost of implementation and the lack of other effective treatment alternatives can present a compelling argument that corporations and other organizations might have a duty of care toward their employees, customers, patrons, etc. who may suffer sudden cardiac arrest. Failure to purchase and use AEDs could conceivably subject these corporations to an increasing liability risk in this rapidly evolving legal arena. It is important to read and understand your specific state law as it pertains to AED's. Find your states AED Law/s

Articles

Adopting an AED program can reduce legal risk - Richard Lazar, Esq.

Choosing the right AED

With so many AED's on the market today, how do you choose the right one? We have developed an AED buyers guide that can help you determine which AED is right for you based on your situation. AED Buyers Guide

AED Placement

Where should we place our AED within our building? We have compiled some guidance for this question. AED Placement

AED Promotion

Before the actual placement of the AED takes place you should make sure that staff have been trained in CPR and AED. We also strongly recommend that there be a effort to widely communicate the placement of the AED to all staff and patrons. No one will use something if they don't know that it exists. If you are a school you should mention the AED and its location in one of your weekly bulletins or other publications. When looking at particular rescues and incidents when AED's were not used and they could of or should have been, it usually comes down to a lack of education or just someone not knowing what an AED is or where it is. This is very important in the overall success of your AED program. Although a person may not be trained to use an AED, you may need them to retrieve it for you in the event of an emergency while you start CPR.

Refresher Training

Make sure refresher training is a part of your plan. It is not a one time thing. Refresher training should be conducted at a minimum of once every 2 years or more frequently if possible. We have many customers that practice and drill on their emergency response and AED plan 2 times per year and they are good. It doesn't take long but it does make a difference.

Congratulate yourself and everyone involved

Congratulations. Your efforts can save lives. We hope the AED collects a lot of dust but We have had some AED customers use their AED multiple times. The implementation process looks daunting but really it can be done very quickly and easily. Remember AEDUniverse.com is always here to help you if you have any questions or need some help getting things moving. We can provide you additional templates and help you out with any questions you may have. 

Remember AEDUniverse.com is your online source for everything "AED's" from AED pads and AED batteries to AED cabinets and AED signs. Find out more information about AED's at AEDUniverse.com.

FDA has cleared Medtronic Physio-Control to ship without restrictions

AEDUniverse.com is pleased to announce that the FDA has lifted restrictions on Medtronic Physio-Control AED's and Defibrillator products. We feel that Physio-Control has made significant improvements in quality and safety standards and will be the gold standard which other manufactures will be graded in the future. Here is what we understand in regards to the shipping status for Medtronic Physio-Control AED products; LIFEPAK 1000 AED's are in stock and available to ship now, LIFEPAK ALS Defibrillators are available to ship and LIFEPAK CR Plus AED back orders will be resolved first then new orders will be shipped around March 2010. AEDUniverse.com is your online source for Medtronic LIFEPAK AED's, AED pads and AED batteries.
 Physio-Control has announced that the LIFEPAK CR Plus will now come standard with an 8 year warranty. The longest AED warranty in the industry!

We are excited about this development and feel that Medtroinc Physio-Control is back and better than ever.

Washington Rule Requiring Dentist to have an AED on premise? Is it still a rule or not?

Short answer is Yes WAC-246-817-722 stands as written. While the Dental Quality Assurance Commission (DQAC) originally repealed the requirement to its rule requiring automated external defibrillators in certain dental offices that administered anesthetic. On May 1, 2009 the DQAC upheld the requirement that requires AED's in Washington state dental offices that administer anesthetic.

While this leaves the original rule (WAC 246-817-722) in effect, DQAC has also begun the administrative process to amend the rule with attention to two issues: exempting offices which administer only topical anesthetics and allowing adjoining offices to jointly comply with the rule using a single AED.

Because opposition to repealing the rule was expressed, DQAC was unable to use the states expedited repeal process. If approved, the revised rule would likely not be effective until March 2010. DQAC members clarified that the commission does have discretion in not pursuing complaints regarding AEDs in the interim.

AEDUniverse.com will be providing Washington Dentists with discounted AED pricing to help meet this requirement.

WAC 246-817-722 Every dental office in the state of Washington that administers anesthetic must have an automatic external defibrillator (AED) or defibrillator. The dentist and staff must be prepared to use this equipment in an emergency.

For more information visit www.aeduniverse.com or www.aed4u.com

Know your regulations before placing an AED.

It is important that when implementing an AED program to have a good understanding of the requirements and regulations in your area as they pertain to AED's. Laws and Regulations for AED's are usually ambiguous and difficult to understand in most cases. AED regulations can vary by state, county and even city. The other difficult part is that there usually isn't a regulatory or overseeing agency to enforce or to go to for questions about AED programs and how to implement them correctly. Here are some things to know:

1.) *AED's require a prescription for purchase regardless of the state. This is a federal requirement

*The exception to this is the Philips Heartstart Onsite AED which has received an exemption from the FDA.

2.) Almost all if not all states require CPR/AED training in order for rescuers to be provided with conditional immunity.

3.) Most states require Physician Oversight for AED programs.

4.) Most states require EMS notification of some sort.

5.) Most states require regular maintenance/inspections for AED's

Knowing the few key regulations can be a real help in trying to determine your specific states requirements. Keep in mind state laws can vary but most are similar in requirements although wording can be different. AEDUniverse.com has complied summaries of AED laws by state, although the laws and regulations are changing constantly. Click here to search AED Laws by State

For more information about AED's and AED programs visit www.aeduniverse.com

Texas Implements AED Legislation

September, 2009 - Texas House Bill 392, which requires the placement of an Automated External Defibrillation (AED) in all nursing homes and related institutions, goes into effect on September 1, 2009.

In 2008, Texas nursing homes served more than 56,000 Texans, some of whom are among the most vulnerable and medically fragile citizens of the state. However, as of 2002, only 4 percent of nursing homes had an AED in their facility. On average among this population, the survival rate of cardiac arrest outside of a hospital without the use of an AED or CPR is about 6 percent. Find our more about AED's at AEDUniverse.com

Don't buy an AED...... Unless your willing to maintain it

One thing that is frustrating to me as an advocate for AED's is when AED's are not maintained properly. Although AED's require very little in the way of maintenance, it is important to recognize that they do have batteries that can deplete over time and the AED pads do expire. So often I will see AED's in public places and well..... I look at them, only to determine that they are not ready for use and if it were needed in a true emergency it may or may not work. Many states have requirements for maintaining AED's but California is specific and says that the AED's must be inspected every 28 days. In general we recommend that AED's be inspected every month.

On an AED there are only 4 main items that should be inspected on a regular basis

1.) Pads expiration date (every set of AED pads is marked with a expiration date
2.) Check the Status indicator. (Every AED has some visual indicator which will let you know the devices state of readiness.)
3.) Battery status (This is not always easy to determine without manually running a self test) Refer to your specific operations maual for details
4.) Check the overall condition of the AED. Is there any visible cracks in the housing? Is it clean?

A monthly AED inspection takes all of about 1 minute to complete but can mean the difference between life and death in an emergency. Having the AED in a visible place will help make sure the inspections get done. You can use an AED Inspection Tag to record your inspections. If you are going to buy an AED or have an AED make sure it is inspected on a regular basis. For more information on inspecting your AED- Inspecting your AED

To purchase replacement pads and batteries for your AED visit www.aeduniverse.com

Oregon Passes Legislation that will require owners of buildings greater than 50,000 sq. ft. to have an AED

New Oregon Law To Take Effect January 2010 Oregon SB 556 which requires owners of buildings greater than 50,000 square feet and 25 or more visitors a day to have a defibrillator and someone trained to use it on site. Schools and churches will be exempt from the requirement. See the full statute

visit us at AEDUniverse.com

New Jersey Passes New AED Legislation that requires AED's in Nursing Homes and Assisted Living Facilities.

The New Jersey bill, S2146 passed both the state Senate and Assembly and was signed into law April 23. It extends to assisted living facilities the same requirements for AED placement and staff training that currently apply to nursing homes and other health-related institutions in the state. Assisted living facilities must meet the requirements of the new law within one year. New Jersey law will require assisted living facilities to have both an automated external defibrillator (AED) and someone trained in its use on site. See the full statute

Philips FR2+ Recall - 5,400 Units

September 28, 2009
PHILIPS ISSUES WORLDWIDE RECALL OF SELECT HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATORS

SEATTLE — Philips announced today that it is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured between May, 2007 and January, 2008 are included in the voluntary recall.

The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The device automatically analyzes the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy.

Philips has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. These reported failures were detected during routine self tests, not during emergency use of the AED. Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated, although Philips has received no reports of injury associated with this chip failure.

The AEDs affected by this recall have been distributed globally to fire departments, emergency medical services, hospitals, and other organizations. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs by sending notification letters to distributors and users. In addition, the company has set up a page on the Philips Web site with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is. The Web page is www.philips.com/FR2PlusAction. Philips has notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product. Customers who have questions about the recall or wish to report product problems may contact HeartStart Customer Service at 1-800-263-3342.

Any adverse events experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

For media inquiries, please contact: Steve Kelly Philips Healthcare Tel: +1 (425) 487-7479 E-mail: steve.kelly@philips.com

Ian Race Philips Healthcare Tel: +1 (978) 659-4624 E-mail: ian.race@philips.com

Visit aeduniverse.com

Philips Heartstart FR2 End Of Life- Information

Philips Healthcare is announcing that, as of May 18, 2009, orders for the HeartStart FR2+ (M3860A, M3861A, M3840A, and M3841A) automated external defibrillator (AED) will no longer be accepted. After nine years on the market, the FR2+ is being discontinued.
Philips will continue to honor the standard five-year warranty for all currently installed FR2+ AEDs, as well as the optional two-year warranty extension available in the United States.

Supplies, training accessories, and technical support for the FR2+ will continue to be available.
For customers who require ECG display voice recording, extended ECG recording, manual override, or three-lead ECG, Philips is actively investigating the feasibility of offering refurbished HeartStart FR2+ devices. For those customers who do not need these features, Philips suggests consideration of the HeartStart FRx AED.

The FRx offers many of the same outstanding features as the FR2+, such as the same consistent, reassuring “voice” customers are already used to; the same pads hand-off capability to arriving EMS, daily self-testing, and compatibility with Philips data management software. In addition, the FRx offers many benefits not shared by the FR2+. Compared to the FR2+, the FRx is:

• Less expensive to own in most environments — lower five-year cost of ownership — same pads for both adult and pediatric defibrillation

• Easier to use — pre-connected pads — CPR Coaching — voice prompts paced to the responder’s action — an Infant/Child key that that automatically reduces the delivered therapy to a level appropriate for a patient under 8 years old or less than 55 lbs (25 kg)

• More robust (500 lbs crush, IP55 rated enclosure) • Quicker in shock delivery, typically within 8 seconds from the end of the patient care pause, compared to 10 seconds for FR2+. Philips continues to shape the future of AED technology. We appreciate the loyalty of our customers
and remain committed to providing products of the highest quality.

If you have questions, please contact AEDUniverse.com at 1-866-517-8243