Philips Electronics issued a Class I Recall for select models of HeartStart MRx defibrillators due to Gas Discharge Tube (GDT) defects. Micro cracks in the GDT may allow internal gasses to escape, impeding tube function. GDT defects can also cause an electrical current surge to cross the device's designated resistors, damaging the resistors and preventing the device from working in automated external defibrillator (AED) mode. Defective devices may fail at any time, and continued use of a defective device may cause serious injury or patient death. If the device fails to function while operating in AED mode, users should switch to manual mode to continue using electrocardiogram display and other monitoring leads to identify a shockable rhythm and deliver therapy manually.

Affected devices include model numbers M3535A and M3536A, manufactured between Sept. 22 and Oct. 31, 2016, and distributed between Sept. 16 and Nov. 2, 2016. Customers should check all inventory for affected models and contact Philips if a device fails to function as intended. Health care professionals are encouraged to report adverse events or side effects related to the use of these products to the U.S. Food and Drug Administration's MedWatch Safety Information and Adverse Event Reporting Program.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias

Keywords: ACC Advocacy, United States Food and Drug Administration, Defibrillators, Equipment Failure, Electrocardiography, Shock

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