Model/Item numbers: M3535A, M3536A. Philips is recalling the HeartStart MRxDefibrillator due to a defect in the device's Gas Discharge Tube (GDT). The GDT has micro cracks which allows internal gasses to escape and causes the tubes to not function as expected. This also permits an electrical current surge to cross the device's designated resistors, which will damage the resistors and prevent the device from working while in automated external defibrillator (AED)mode. As a result of this GDT defect, the HeartStart MRx may fail at any time,including when delivering repeated shocks in AED mode, or during the periodicOperational Check outlined in the device's Instructions for Use. If the device is used in AED mode after failure, the device will not deliver patient therapy.Continued use of the device in AED mode after failure may lead to serious patient injury or death.
Posted 2/24/2017 FDA Link
