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Dec. 3, 2013 - FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare
Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices.
The safety communication includes recommendations to better inspect and monitor the readiness of these devices, as well as steps to follow if someone must use a recalled device in an emergency situation.
Customers (both consumers and first responders) who have received the affected devices should contact Philips Healthcare at 1-800-263-3342 to receive a replacement AED unit. Until a replacement is received, the agency does recommend keeping the recalled defibrillators in service because it considers the benefits of attempting to use the device in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator, said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health, in a statement Tuesday
An AED 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. Each year, nearly 300,000 Americans collapse from sudden cardiac arrest. When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death.
In September 2012, Philips Healthcare initiated the recall of HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs due to the failure of an internal electrical component. The recall affected approximately 700,000 devices.
In a Medical Device Safety Notice dated November 19, 2013, Philips provided consumers with updated information about the failure of an internal electrical component that could cause the AEDs to fail to deliver a shock. The notification also directed users to a Maintenance Advisory.
The FDA will continue to closely monitor all AED manufacturers’ quality system practices and manufacturing changes that have persistently contributed to recall and adverse events associated with AEDs.
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.
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