Philips Healthcare is recalling 47,362 HeartStart MRx Monitor/Defibrillators due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy, according to the FDA. The device may also unexpectedly stop pacing. A delay in delivering therapy could result in serious patient injury, such as permanent organ damage, brain injury, or death.
The recall includes devices manufactured between February 11, 2004, and November 4, 2016, the FDA says. The agency labelled this a Class I recall, its most serious category.
The HeartStart MRx Monitor/Defibrillator is used to pace people with a slow heartbeat or to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Electrodes are attached to the patient and then connected to the device to help it analyze a patient's heart rhythm. The electrodes deliver an electrical shock to restore a normal heart rhythm during sudden cardiac arrest, or to pace the heart at a normal rate when it slows down. The HeartStart MRx Monitor/Defibrillator is intended for use by medical professionals who are trained in cardiopulmonary resuscitation.
In February, Philips Healthcare sent an “Urgent Medical Device Correction” notice to its customers. The company recommended inspecting the battery connector pins to make sure they are clean, fully extended, and free of residue.
The affected devices can be identified using the model number information. The recall covers these model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
Customers can contact Philips Healthcare for further information or support at 1-800-722-9377.
Source: FDA; March 24, 2017.