FDA issues safety communication regarding HeartStart automated external defibrillators

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday issued a safety communication on HeartStart automated external defibrillators from Philips Healthcare, noting that certain HeartStart AED devices may be unable to deliver needed defibrillator shock in a cardiac emergency situation.

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,” stated 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.”

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 for a replacement AED unit.

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. 

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.