China NMPA Product Recall - Ventilator (Monnal T50)

Air Liquide Medical Systems S.A., through its agent Air Liquide Medical Supplies (Beijing) Co., Ltd., initiated a Level II voluntary recall of certain ventilators (CFDA (Imported) No. 20143530589). This action, reported on June 19, 2017, and published by the National Medical Products Administration (NMPA) on July 18, 2017, addresses two critical issues. The primary concern is a defect in the power board of ventilators with serial numbers preceding MT50-04540. This flaw can lead to an unexpected loss of 5V voltage, causing the device to suddenly shut down. Additionally, the manufacturer identified that improper use of the built-in battery by overseas home users could result in a significant drop in effective battery charge, leading to an abrupt shutdown when operating solely on battery power. Globally, 4267 units were affected, with 7 units identified in China. Under NMPA regulations, the company is implementing several corrective actions. These include immediately instructing six affected hospitals to cease using the identified ventilators, offering backup devices, and issuing a nationwide reminder to all hospitals utilizing this ventilator model to diligently monitor and timely charge batteries. Furthermore, external alarm devices are being provided to the six affected hospitals. These alarms will activate upon unexpected shutdown, alerting users to take immediate action to maintain patient ventilation. The company also committed to implementing the manufacturer's final solution for these hospitals promptly upon its release.