FDA Issues AED Safety Communication

162017_132140396847214_292624_nAn AED (automated external defibrillator) is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly. When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death. Nearly 300,000 Americans each year collapse from sudden cardiac arrest.

On December 3, 2013, the FDA issued a safety communication regarding certain HeartStart AEDs made by Philips Medical Systems (a division of Philips Healthcare) because they may be unable to deliver needed defibrillator shock in a cardiac emergency situation. In September 2012, Philips had recalled its HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs manufactured between 2005 and 2012 because the failure of an internal electrical component may cause the devices to fail to deliver a shock in the event of an emergency.

In March 2013, the FDA issued a proposed order that if finalized would require manufacturers of AEDs and accessories to submit premarket approval applications that focus specifically on the critical requirements necessary to assure AEDs are safe and effective. The main objective of this proposed regulatory approach is to improve the reliability of AEDs so that they can continue to save lives.


Philips Voluntary Medical Device Recall (HeartStart FR2+)

Philips voluntarily recalled a limited number of its HeartStart FR2+ because the devices contained a voltage detector from lots that were found to exhibit a higher than expected rate of failure. Failure of the voltage detector can cause the AED battery to drain more rapidly than normal or to render it unusable when needed in an emergency.

Philips reported that the problem is detected by the HeartStart FR2+ and shown on the status indicator. There were no reported incidents of the problem during emergency use of the AED, and no reported injuries to users or patients.


Philips Voluntary Medical Device Recall (HeartStart HS1 and FRx Defibrillators Produced In October 2009)

Philips voluntarily recalled a limited number of its OnSite, First Aid, HS1, and Home defibrillators (HS1) and FRx defibrillators manufactured in October 2009 because the devices contained a capacitor not meeting its quality standards. Failure of the capacitor during use could prevent the AED from delivering effective defibrillation therapy when indicated.

Affected devices were HS1 (models M5066A and M5068A) and FRx (model 861304) automated external defibrillators. The HS1 defibrillators were sold in North America as HeartStart OnSite and HeartStart Home, and internationally as HeartStart HS1, HeartStart First Aid or HeartStart Home defibrillators. There were no reports of capacitor failure in the affected devices that had been shipped.


If you or a loved one suffered serious injuries or death as a result of a defective AED or another defective medical device, you should promptly seek the legal advice of a defective medical device lawyer (or a medical malpractice lawyer) in your state who may investigate your defective medical device claim for you and represent you in a medical device lawsuit, if appropriate.

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This entry was posted on Friday, December 13th, 2013 at 9:09 am. Both comments and pings are currently closed.


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