FDA Says Philips Defibrillator May Not Work

A faulty electronic component in some Philips HeartStart automated external defibrillators may prevent the device from delivering a needed shock to a person suffering a cardiac emergency, the FDA recently warned.


The Dutch multinational's Philips Healthcare subsidiary in September 2012 initiated a recall of about 700,000 HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs, according to the FDA. Philips is offering free replacement of the devices, which were manufactured and distributed between 2005 and 2012.

An automated external defibrillator analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. The HeartStart FRx, as shown on Philips' website.

Here's how Philips describes the problem, which involves electrical components called relays that came from a single manufacturing lot:

"Possible contamination on the relay surface could compromise its performance over time and affect the AED's ability to make a therapy decision during use. No other Philips defibrillators are affected by this action. This issue was discovered in the Philips factory during monitoring and analysis of our manufacturing processes. At this time, we have received no reports of relay failure in affected devices that have been shipped. Although the devices subject to this recall are not expected to experience the issue, the potential for this failure does not meet Philips performance expectations. As a precaution, we are proactively retrieving all units that may contain a defective capacitor."

The FDA is advising that the AEDs should stay in use until health providers obtain the free replacements.

"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," Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health, said in a news release.

The device is also supposed to emit a triple chirp sound and have a flashing "i-button" if it detects a serious problem that could prevent electrical shock delivery. The FDA says contact Philips immediately for a replacement in such a situation, and also has instructions about what people should do if the defibrillator malfunctions in an actual emergency situation.

AED reliability is a serious enough issue that the FDA hasissued 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.




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