Defibrillator Might Not Be Dependable

FDA warns HeartStart AED defibrillator by Philips Medical Systems might not perform

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) If you are reaching for a defibrillator, the situation is likely one of life or death. But a new announcement warns that a certain type of defibrillator might not perform in that emergency.

The US Food and Drug Administration (FDA) warned this week that certain HeartStart automated external defibrillator (AED) devices might not be able to deliver the shock intended during an emergency situation.

The FDA suggested that consumers and first responders alike keep the devices until they receive a replacement.

"Learn where a defibrillator is kept in your workplace."

The devices in the FDA's warning include the HeartStart FRx, HeartStart HS1 Home and HeartStart HS1 OnSite AEDs. These devices were produced by Philips Medical Systems and distributed between the years 2005 and 2012.

"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," explained the FDA. "AEDs help save lives of cardiac arrest victims when they are working properly and used correctly."

The AEDs in question were previously involved in a 2012 recall by Phillips due to issues with an electrical component within the device. In November of this year, Philips issued a statement about an electrical issue that could lead to the devices' failure to deliver the necessary shock.

The FDA urged users of these devices, who might be consumers or who might be professional first responders, to contact Phillips immediately in order to receive a replacement device. However, the public is also encouraged not to discard the AEDs until that replacement is received.

“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,” explained Steve Silverman, of the FDA’s Center for Devices and Radiological Health, in a news release.

“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,” said Silverman.

The FDA reported that nearly 300,000 Americans experience sudden cardiac arrest each year, situations that could be mediated with an AED. When heart rhythms are not normalized quickly, death can occur.

"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," the FDA noted.

Review Date: 
December 4, 2013
Last Updated:
December 5, 2013