China NMPA Product Recall - Emergency and Transport Ventilator

Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Oxylog VE300 Emergency and Transport Ventilator, as reported to the National Medical Products Administration (NMPA) and published on February 12, 2020. This action followed the company's continuous market monitoring, which identified an incident where a ventilator detached from its portable system fixation device. The root cause was attributed to a missing shaft within the accessory mechanism at the bottom of the device, preventing it from securely locking into place.

Although the reported incident did not result in any patient or user injury, Drägerwerk AG & Co. KgaA, the parent company, determined that the weight of the equipment presented a potential risk of personal injury if a similar event were to recur. The recall specifically targets Emergency and Transport Ventilators with Registration Certificate No. 20193080442. Detailed information regarding affected product models, specifications, and batches is available in the "Medical Device Recall Event Report Form" attachment. This recall underscores the importance of stringent product design and post-market surveillance in ensuring medical device safety under the NMPA's regulatory oversight.