China NMPA Product Recall - Ventilator/Ventilator Therapy System

Dräger Medical Devices (Shanghai) Co., Ltd., a subsidiary of Draegerwerk AG & Co. KGaA, initiated a Level I voluntary recall for specific models of its ventilators and respiratory therapy systems equipped with the PS500 auxiliary power supply. This recall, reported to the National Medical Products Administration (NMPA) on February 21, 2017, and published on March 17, 2017, addresses an ongoing issue with the PS500's optional external battery. The core problem is that the battery provides less power than anticipated and fails to trigger a low-battery alarm sufficiently early, although a power failure alarm activates upon complete device power loss. This report serves as the final documentation for corrective measures initially announced in February 2016 via a safety bulletin. The involved products include the Evita Infinity V500, Babylog VN500, Evita V300, and PS500 Auxiliary Power Supply, with 15 units sold or imported into China, affecting global regions. To resolve the defect, Dräger implemented several critical actions: upgrading the equipment's system software, replacing the faulty external battery and power supply unit, and installing additional internal batteries to enhance device reliability and patient safety.