China NMPA Product Recall - Defibrillation/monitoring system

On April 17, 2019, the National Medical Products Administration (NMPA) issued a Level 1 voluntary recall initiated by Physio-Control, Inc. for its LIFEPAK 15 defibrillator/monitoring systems. The critical issue identified is that certain devices may enter an unresponsive "locked state" following a defibrillation shock. This condition, characterized by a blank monitor and non-functional controls despite the device being powered on, stems from a software defect impacting the watchdog timer on the printed circuit board. The malfunction could lead to significant treatment delays, potentially resulting in serious injury or death. Globally, 298 units in China are affected. In response, Physio-Control, Inc. has outlined several required actions. Customers are instructed to perform daily checks by discharging the equipment to identify any locked states. Temporary remedies, such as power cycling or battery removal, are to be incorporated into the instruction manual. Any device found to be in a locked state during these checks must be immediately disabled and replaced with an alternative defibrillation unit. The long-term corrective action involves updating the printed circuit board firmware to permanently resolve the software defect, an update confirmed effective through testing.