China NMPA Product Recall - Ventilator/Respiratory Therapy System

Dräger Medical Devices (Shanghai) Co., Ltd. initiated a Class I voluntary recall of ventilators and respiratory therapy systems due to a persistent battery defect in the optional PS500 auxiliary power supply. This recall, overseen by the National Medical Products Administration (NMPA) and reported on February 21, 2017 (with publication on March 17, 2017), serves as a final report on corrective actions following initial measures in February 2016.The primary issue identified was that the PS500 auxiliary power supply provided less power than anticipated and failed to issue a low-battery alarm sufficiently early. While a power failure alarm was generated upon complete device power loss, the absence of timely low-battery warnings posed a significant risk.Affected products include specific models of Infinity ACS Workstation Critical Care (Evita Infinity V500), Infinity ACS Workstation Neonatal Care (Babylog VN500), Evita V300, and the PS500 Auxiliary Power Supply itself, impacting global markets including China. To rectify the defect, Dräger issued safety notices to users. Required actions involve maintenance personnel upgrading the equipment's system software, replacing the faulty external battery, and installing an additional internal battery to enhance patient safety and device reliability.