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© vkoletic-dreamstime.com Electronics Production | December 06, 2013

Resistor may cause Philips defibrillators to fail

U.S. regulators have warned that some automated external defibrillators made by Philips Medical Systems may be unable to deliver potentially life-saving shocks to the heart in emergency situations, due to an electronic product malfunction.
Philips’ HeartStart AED safety notification states that under extremely rare circumstances, an internal electrical component – a resistor – may fail when high voltage is applied, which in some cases may result in the inability of the AED to deliver a shock when needed. The safety notification affected approximately 605'000 HeartStart AEDs worldwide, of which 61 units have been returned for service or replacement since the devices’ deployment between 2005 and 2012. Philips has not received any reports of patient harm due to this issue.

“If the device indicates it has detected an error during a self-test the FDA advises users to keep recalled HeartStart AEDs in service until a replacement from Philips Healthcare or another AED manufacturer is obtained,” 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.”

“Philips treats patient and operator safety as our primary concern, and we remain committed to the highest standards of product quality and compliance with government safety regulations for medical devices,” said Deborah DiSanzo, Chief Executive Officer of Philips Healthcare.
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December 05 2018 3:01 pm V11.10.4-1