December 11th, 2013

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, according to a new safety communication issued by the U.S. Food and Drug Administration to users of these previously recalled devices.

These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. Users, who may include consumers and first responders, should contact Philips Healthcare immediately for a replacement AED unit.

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.

"The FDA advises keeping all recalled HeartStart AEDs in service until you obtain a replacement from Philips Healthcare or another AED manufacturer, even if the device indicates it has detected an error during a self-test," said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health. "Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator."

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.

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.

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.

For more information:

• FDA Medical Devices
• FDA Safety Communication: Philips HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite Automated External Defibrillators (AED)
• FDA issues proposal to improve the quality of automated external defibrillators
• Philips Maintenance Advisory