China NMPA Product Recall - Semi-automatic external defibrillator

Physio-Control, Inc. initiated a voluntary global recall of its LIFEPAK 1000 semi-automatic external defibrillators, as announced by the National Medical Products Administration (NMPA) on October 11, 2017. The recall, categorized as Level 1 due to potential for serious harm or death, addresses a critical issue where devices may unexpectedly shut down during patient treatment. This malfunction stems from intermittent poor contact between the battery and the device's electrical contacts, caused by wear and subsequent oxidation, particularly when devices are used under vibration and batteries are left installed for extended periods without inspection. Physio-Control, Inc., through its distributor Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., instructed customers to immediately remove and reinstall the LIFEPAK 1000 battery. Users are required to regularly perform this battery reinstallation weekly to clean contacts and reduce oxidation, keep a fully charged spare battery, and arrange for repair service if the issue persists. In China, 602 affected units were imported, with 361 units sold.