China NMPA Product Recall - LIFEPAK 1000 Semi-automatic External Defibrillator

Physio-Control, Inc., in collaboration with its agent Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., issued a Level I voluntary global recall for its LIFEPAK 1000 Semi-Automatic External Defibrillator. This action, reported to the National Medical Products Administration (NMPA) on September 28, 2017, and published on October 10, 2017, was prompted by reports of unexpected device shutdown during patient treatment. The critical issue stems from intermittent poor contact between the battery and the device's electrical contacts, resulting from wear and subsequent oxidation, particularly when the device is used under vibration and the battery remains installed for extended periods without reinstallation. This malfunction could prevent the defibrillator from operating during resuscitation, posing a severe risk of harm or death to patients. As required actions, customers are instructed to immediately remove and reinstall the battery to clean oxidized contacts and reduce future oxidation. Furthermore, regular weekly removal and reinstallation of all LIFEPAK 1000 batteries are mandated to ensure operational readiness, along with maintaining a fully charged spare battery. Should the problem persist, repair services will be arranged.