HeartStart MRx Defibrillator by Philips Electronics: Class I Recall – Defects in Gas Discharge Tubes May Cause Device Failure
Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device’s Gas Discharge Tube (GDT). Hazard: 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.
For more information, please visit FDA (see lot numbers): http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm596134.htm
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