AUDIENCE: Emergency Medicine, Risk Manager, Nursing
ISSUE: Philips is recalling the HeartStart MRx Defibrillator 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 periodic Operational 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.
However, the HeartStart MRx will continue to work in “Manual” mode after AED mode failure, though the electrocardiogram (EKG) displayed on the device will be noisy, which may make provider interpretation difficult.
BACKGROUND: The HeartStart MRx Monitor/Defibrillator is intended for use by or on the order of a physician, and should only be administered by medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation.
RECOMMENDATION: On June 13, 2017, Philips Electronics sent affected customers a “Medical Device Correction Notification” informing them of the device’s risks. In the letter, Philips directed customers to:
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch Safety Alert, including a link to the FDA recall notice, at: