China NMPA Product Recall - SERVO-i ventilator

The National Medical Products Administration (NMPA) announced on September 22, 2013, a voluntary recall initiated by Maquet Critical Care AB, through its Chinese entity Maquet (Shanghai) Medical Equipment Co., Ltd. The recall, reported by Maquet on August 30, 2013, targets SERVO-i ventilators, specifically battery modules (part number: 6487180) manufactured between February 2010 and October 2012. The primary issue identified is that a small number of these battery modules provide a power supply time shorter than their expected duration. This malfunction poses a potential risk of temporary ventilation cessation if the device operates solely on battery power and the battery depletes unexpectedly. While the ventilator provides low-battery alarms, an unattended patient could face serious harm, though no patient injuries have been reported. Under the NMPA's oversight, Maquet's corrective actions include issuing a "Safety Warning Notice" to affected customers, detailing proper handling measures. Furthermore, Maquet is committed to providing free replacements for any battery modules that trigger "Low Battery Voltage" or "Replace Battery" alarms during their service life. Provincial regulatory bodies were also instructed to enhance supervision of such medical products. The recall affects 1680 battery modules sold in Mainland China.