China NMPA Product Recall - LIFEPAK 1000

Physio-Control, Inc. initiated a Level I voluntary recall for its LIFEPAK 1000 Semi-automatic External Defibrillator, as reported to the National Medical Products Administration (NMPA) on September 28, 2017, and published on October 10, 2017. The recall, managed in China by Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., addresses a critical safety issue: the device may unexpectedly shut down during patient treatment, rendering it inoperable during resuscitation and posing a risk of serious harm or death.Investigation revealed the root cause to be intermittent poor contact between the battery and the device’s electrical contacts. This poor contact is attributed to wear, tear, and subsequent oxidation occurring over time, particularly when the device is subjected to vibration and the battery remains installed for extended periods without removal, inspection, or reinstallation.Physio-Control requires customers to immediately remove and then reinstall the battery from their LIFEPAK 1000 defibrillators to clean oxidized contacts and mitigate future oxidation. Furthermore, users must regularly remove and reinstall all LIFEPAK 1000 batteries weekly and maintain a fully charged spare battery. If the unexpected shutdown problem persists after these actions, customers are advised to arrange for repair service. This global recall affects approximately 361 units in China.