Philips Healthcare has released the following statement regarding a recent FDA Communication
In August 2012, Philips initiated a voluntary safety notification regarding the company’s HeartStart FRx, HeartStart Home, and HeartStart OnSite Automated External Defibrillator (AED) devices, due to the remote possibility of a hazard associated with the potential failure of an internal electrical component. In January 2013, the U.S. Food and Drug Administration (FDA) classified this action as a Class II recall, where the probability of serious adverse health consequences is remote. The safety notification affected approximately 605,000 HeartStart AED devices worldwide, of which nearly 284,000 are in the U.S.
Philips HeartStart FRx and HS1 (OnSite and Home) AEDs include an electrical component called a resistor that, under extremely rare circumstances, may fail when high voltage is applied. In some cases, resistor failure can result in an AED that is unable to deliver a shock when needed. Although a resistor failure is unlikely, it will be detected by the AED’s automated periodic self-test feature, and result in an audible triple-chirp alert, which is a signal for a customer to contact Philips immediately for service.
Beginning in September 2012, Philips began notifying customers of this potential issue and the importance of contacting the company in the case of an audible triple-chirp alert resulting from AED device self-testing.
Calling Philips for technical support if the device has ever emitted or begins to emit a pattern of triple chirps is the only way to be certain that the AED will be ready for use in an emergency. If an AED begins to emit a pattern of triple chirps during an emergency use, customers are advised to follow all voice instructions provided by the device. Once the emergency is resolved, Philips urges customers to contact their local Philips representative immediately.
Philips has not received any reports of patient harm due to this issue. Philips treats patient and operator safety as our primary concern, and the company has been working closely with regulatory authorities and with customers to address this issue.
SOURCE: Philips