China NMPA Product Recall - Defibrillation/monitoring system

The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Physio-Control, Inc. on November 29, 2016, based on a report dated October 18, 2016, from Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd. The recall pertains to the LIFEPAK 15 defibrillator/monitoring system (NMPA Registration Certificate No. 20123212890 (Updated)). The central issue involves a display anomaly where, if end-tidal carbon dioxide (EtCO2) monitoring is set to kPa or % units and the reading exceeds 9.9, the respiratory rate display may partially obscure the first digit of the EtCO2 value. This visual defect could lead to a high EtCO2 reading being misinterpreted as low, potentially resulting in incorrect patient treatment. While no patient harm or inappropriate treatment has been reported due to this issue, the recall affects 105 units imported and sold in China, with a global impact. Under NMPA guidance, required actions include informing all distributors and users, advising users to closely monitor EtCO2 waveforms and display ranges, activate EtCO2 alarms, and consider changing the unit setting to mmHg. Additionally, Physio-Control will release and notify users of a system software update through its official website when available.