www.fdanews.com/articles/196411-philips-warns-of-heartstart-monitordefibrillator-failures
Philips Warns of HeartStart Monitor/Defibrillator Failures
March 27, 2020
Philips has issued an urgent medical device correction for certain HeartStart MRx monitor/defibrillator devices, warning that some devices may lose their ability to deliver therapy if dropped or subjected to shocks.
Despite showing no signs of damage, a number of the devices suffered internal damage after being dropped or subjected to mechanical shocks, making them unusable for therapy.
If a device may be needed for therapeutic use before its next automatic self-test or manual operational check, Philips said users should perform a manual check if the device is dropped, subjected to mechanical shock or mishandled.