# China NMPA Product Recall - Ventilator/Ventilator Therapy System

Source: https://www.globalkeysolutions.net/records/china_product_recall/draegerwerk-ag-co-kgaa/2ecddba6-a58b-4fca-a503-55c74e17c623/
Source feed: China

> China NMPA product recall for Ventilator/Ventilator Therapy System by Draegerwerk AG & Co. KGaA published March 17, 2017. Recall level: Class I Recall. Dräger Medical Devices (Shanghai) Co., Ltd., a subsidiary of Draegerwerk AG & Co. KGaA, initiated a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dräger Medical Devices (Shanghai) Co., Ltd. initiates voluntary recall of ventilators/respiratory therapy systems
- Company Name: Draegerwerk AG & Co. KGaA
- Publication Date: 2017-03-17
- Product Name: Ventilator/Ventilator Therapy System
- Recall Level: Class I Recall
- Recall Reason: The optional external battery provided less power than expected during use, but did not generate a low battery alarm early enough. In each reported event, a power failure alarm should be generated when the device loses power.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Draegerwerk AG & Co. KGaA
- Summary: Dräger Medical Devices (Shanghai) Co., Ltd., a subsidiary of Draegerwerk AG & Co. KGaA, initiated a Level I voluntary recall for specific models of its ventilators and respiratory therapy systems equipped with the PS500 auxiliary power supply. This recall, reported to the National Medical Products Administration (NMPA) on February 21, 2017, and published on March 17, 2017, addresses an ongoing issue with the PS500's optional external battery. The core problem is that the battery provides less power than anticipated and fails to trigger a low-battery alarm sufficiently early, although a power failure alarm activates upon complete device power loss. This report serves as the final documentation for corrective measures initially announced in February 2016 via a safety bulletin. The involved products include the Evita Infinity V500, Babylog VN500, Evita V300, and PS500 Auxiliary Power Supply, with 15 units sold or imported into China, affecting global regions. To resolve the defect, Dräger implemented several critical actions: upgrading the equipment's system software, replacing the faulty external battery and power supply unit, and installing additional internal batteries to enhance device reliability and patient safety.

Company: https://www.globalkeysolutions.net/companies/draegerwerk-ag-co-kgaa/14744193-3c0e-42ad-b561-ad95278db9af/