China NMPA Product Recall - LIFEPAK CR PLUS

The National Medical Products Administration (NMPA) announced a Class I voluntary recall initiated by Physio-Control, Inc., reported on November 24, 2016, and published on November 25, 2016. The recall pertains to Automated External Defibrillators (AEDs), specifically the LIFEPAK CR PLUS model, distributed globally by entities including Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd. The primary issue identified is an intermittent malfunction of an internal reed switch, causing it to remain in the OFF position after the device cover is opened and the ON/OFF button is pressed. This critical defect prevents the AED from activating voice prompts and delivering necessary therapeutic electrical shocks, thereby potentially failing to defibrillate patients and achieve therapeutic efficacy during cardiac arrest. This poses a serious health risk, leading to the Class I designation. As required actions, Physio-Control has notified affected customers and is implementing corrective measures. These include arranging for device calibration, which entails replacing the faulty reed switch assembly, or providing alternative functional devices to ensure patient safety and product reliability.