Philips Healthcare (NYSE:PHG) is alerting customers worldwide that an AC power module in its HeartStart MRx defibrillator/monitor may fail at a higher-than-expected rate.
In a letter dated “June 2019,” the company said the problems could stem from an internal component failure, excess solder during manufacture, physical damage in the field, or the power module reaching the end of its useful life.
If the AC power module fails without a charged battery installed, heart monitoring may be interrupted or shock/pacing therapy delayed, the company said.