# China NMPA Product Recall - Ventilator/Respiratory Therapy System

Source: https://www.globalkeysolutions.net/records/china_product_recall/draegerwerk-ag-co-kgaa/8922d207-599b-4cce-a3e6-73e0620d7f02/
Source feed: China

> China NMPA product recall for Ventilator/Respiratory Therapy System by Draegerwerk AG & Co. KGaA published April 06, 2017. Recall level: Level I. Dräger Medical Devices (Shanghai) Co., Ltd. initiated a Class I voluntary recall of specific ventila

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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: 2017-04-06
- Product Name: Ventilator/Respiratory Therapy System
- Recall Level: Level I
- Recall Reason: This recall only affects devices equipped with the optional PS500 auxiliary power supply and the affected PS500 auxiliary power supplies. Dräger issued a safety bulletin in February 2016 regarding the optional PS500 auxiliary power supply for ventilators and respiratory therapy systems. This corrective action was implemented because the optional external battery was providing less power than expected during use and was not generating a low battery alarm early enough. In every reported incident, 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. initiated a Class I voluntary recall of specific ventilator and respiratory therapy systems due to a persistent battery defect in the optional PS500 auxiliary power supply. This action, reported to the National Medical Products Administration (NMPA) on February 21, 2017, follows an initial safety bulletin issued in February 2016 concerning the same issue. The primary concern was that the PS500 external battery provided insufficient power and failed to trigger a low-battery alarm in a timely manner, although a power failure alarm would activate upon complete power loss. Products affected include various models of the Infinity ACS Workstation Critical Care, Infinity ACS Workstation Neonatal Care (Babylog VN500), Evita V300, and the PS500 Auxiliary Power Supply itself. These devices, registered under NMPA certificates, are used for critical care and mechanical ventilation across different patient populations, including newborns. To address the critical safety concern, Dräger mandated comprehensive corrective actions, which involve upgrading the equipment's system software, replacing the external battery and power supply unit, and installing supplementary internal batteries. This recall underscores the importance of stringent battery performance and alert systems in life-supporting medical devices to ensure patient safety.

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