China NMPA Product Recall - Ventilator (Model: AVEA)

CareFusion Shanghai Trading Co., Ltd. initiated a voluntary recall for its AVEA model ventilators, as reported on October 8, 2013, and published by the National Medical Products Administration (NMPA) on November 7, 2013. The recall addresses a potential issue where the ventilator may underreport tidal volume. This specific concern arises only when the device is used for neonatal patients at altitudes of 1,524 meters or higher, concurrently with a reusable proximal hot-wire flow sensor. While five related complaints were received globally, no actual patient injuries or complaints within China were reported, and adult/pediatric use remains unaffected at any altitude. The NMPA requested provincial administrations to enhance supervision over such products. To rectify the issue, CareFusion will implement a software upgrade for all affected AVEA ventilators. This upgrade will be performed on-site by authorized service agents, with technical support from CareFusion. Customers will receive notification letters detailing the situation. Prior to the software update, hospitals using comprehensive AVEA configurations for neonates at high altitudes should switch to a disposable flow sensor. Those with standard configurations are advised to temporarily discontinue neonatal use until the upgrade is complete. On-site corrections commenced in October 2013, with completion for high-altitude hospitals anticipated by January 2014.