China NMPA Product Recall - Respiratory therapy system/ventilator

Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall on July 16, 2015, impacting specific respiratory therapy systems and ventilators. The recall, reported to the National Medical Products Administration (NMPA), addresses a critical issue with devices utilizing the optional PS500 auxiliary power supply. The primary concern is that during patient transport, when the main power is disconnected, the PS500 auxiliary power supply inaccurately displays "Low Battery" and "Battery Depleted" alarms. This prevents proper prediction of remaining ventilation time, despite the battery status being low. Affected products include various models of the Infinity Acute Care System Workstation (Critical Care and Neonatal Care) and the Evita V300 ventilator, intended for use in hospitals for both fixed applications and in-hospital patient transport across different patient demographics (neonates, adults, and pediatric patients). To mitigate the risk, Dräger Medical Devices (Shanghai) Co., Ltd. implemented two corrective actions: issuing safety notices to all affected customers and performing on-site replacements of the PS500 auxiliary power supply battery in the involved units. This proactive recall aims to ensure the continued reliability and safety of their life-supporting medical devices.