China NMPA Product Recall - Semi-automatic external defibrillator

Physio-Control, Inc. has initiated a global Level 1 voluntary recall of its LIFEPAK 1000 semi-automatic external defibrillators. This action was reported by Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd. to the National Medical Products Administration (NMPA) on September 28, 2017, and publicly announced on October 11, 2017. The recall addresses a critical safety concern where the defibrillators may unexpectedly shut down during patient treatment. This malfunction is caused by intermittent poor contact and subsequent oxidation between the battery and the device's electrical contacts, particularly when batteries remain installed for extended periods under vibration without routine removal and reinstallation.

This defect presents a significant risk, potentially leading to serious patient harm or death if the defibrillator fails during resuscitation. The recall impacts 602 units manufactured or imported into China, with 361 units already sold. Under the NMPA's regulatory oversight, Physio-Control, Inc. requires customers to take immediate and ongoing corrective actions. Users must promptly remove and reinstall the LIFEPAK 1000 defibrillator battery to clean oxidized contacts. Furthermore, weekly removal and reinstallation of batteries for all LIFEPAK 1000 devices are essential to ensure equipment readiness. A fully charged spare battery should also be kept on hand. If the issue persists, customers are advised to arrange for repair services.