China NMPA Product Recall - Ventilator (Model: AVEA)

CareFusion (Shanghai) Trading Co., Ltd. initiated a Class III voluntary recall of its AVEA® ventilators, as reported to the National Medical Products Administration (NMPA) on May 27, 2016. The recall addresses a critical safety concern involving a defective F1 fuse on the ventilator's Sensor Communication Alarm (TCA) panel. This defect can cause the User Interface Module (UIM) to lose power, resulting in a blank display and the device entering an inoperative (INOP) state, thereby terminating patient ventilation. Although a clinical audible alarm activates and a safety valve opens to allow for spontaneous breathing, the device's primary function of continuous respiratory support is compromised. The company noted an extremely low incidence rate, with no reported patient injuries. Under the NMPA's regulatory oversight, CareFusion's required actions include immediately instructing customers to discontinue use of affected ventilators exhibiting these symptoms and to switch to alternative ventilation devices. Additionally, CareFusion is supplying customers with the necessary repair parts to replace the faulty fuses on all impacted units. The recall applies to 40 units imported into China, with 31 already distributed to end-users.