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FDA Issues Safety Communication on Defibrillators

Certain automated external devices don’t deliver needed shock (December 3)

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 FDA said 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.

“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 a recall of HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs because of the failure of an internal electrical component. The recall affected approximately 700,000 devices.

Source: FDA; December 3, 2013.

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