China NMPA Product Recall - Semi-automatic external defibrillator

On October 11, 2017, the National Medical Products Administration (NMPA) announced a Level 1 global recall initiated by Physio-Control, Inc., for its LIFEPAK 1000 semi-automatic external defibrillators. Distributed in China by Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., these devices presented a critical safety issue: the potential for unexpected shutdown during patient treatment. This malfunction posed a serious risk, potentially leading to severe harm or death if the defibrillator failed during resuscitation efforts. The core problem was identified as intermittent poor contact between the battery and device electrical contacts, resulting from wear and oxidation, especially when devices were used under vibration or batteries were installed for extended periods without re-installation. As a required action under this regulatory framework, Physio-Control, Inc. instructed customers to immediately remove and reinstall the defibrillator battery to clean contacts and mitigate oxidation. Furthermore, users were advised to regularly (weekly) remove and reinstall batteries in all LIFEPAK 1000 devices, maintain a fully charged spare battery, and contact for repair service if the problem persisted.