China NMPA Product Recall - Semi-automatic external defibrillator

The National Medical Products Administration (NMPA) announced a Level I global voluntary recall on October 10, 2017, initiated by Physio-Control, Inc., for its LIFEPAK 1000 semi-automatic external defibrillator (NMPA registration 20163212101). The recall, managed by agent Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., addresses a critical safety concern: the device may unexpectedly shut down during patient treatment, potentially failing to function during resuscitation and posing a risk of serious harm or death. The issue stems from intermittent poor contact between the battery and the device's electrical contacts, caused by wear and subsequent oxidation. This problem is observed to be aggravated under conditions of vibration and prolonged battery installation without routine removal, inspection, and reinstallation. To rectify this, Physio-Control requires customers to immediately remove and reinstall the battery in all affected LIFEPAK 1000 units to clean oxidized contacts. Users must also regularly remove and reinstall all spare LIFEPAK 1000 batteries weekly and ensure a fully charged spare battery is readily available. For persistent problems, repair services will be arranged.