China NMPA Product Recall - Ventilator/Respiratory Therapy System

Dräger Medical Devices (Shanghai) Co., Ltd. initiated a Class I voluntary recall of specific ventilator and respiratory therapy systems due to a persistent battery defect in the optional PS500 auxiliary power supply. This action, reported to the National Medical Products Administration (NMPA) on February 21, 2017, follows an initial safety bulletin issued in February 2016 concerning the same issue. The primary concern was that the PS500 external battery provided insufficient power and failed to trigger a low-battery alarm in a timely manner, although a power failure alarm would activate upon complete power loss. Products affected include various models of the Infinity ACS Workstation Critical Care, Infinity ACS Workstation Neonatal Care (Babylog VN500), Evita V300, and the PS500 Auxiliary Power Supply itself. These devices, registered under NMPA certificates, are used for critical care and mechanical ventilation across different patient populations, including newborns. To address the critical safety concern, Dräger mandated comprehensive corrective actions, which involve upgrading the equipment's system software, replacing the external battery and power supply unit, and installing supplementary internal batteries. This recall underscores the importance of stringent battery performance and alert systems in life-supporting medical devices to ensure patient safety.