# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/koo-medical-equipment-shanghai-co-ltd/335865dc-ce25-4b75-8325-7d43332f924d/
Source feed: China

> China NMPA product recall for Ventilator by Koo Medical Equipment (Shanghai) Co., Ltd. published February 21, 2017. Recall level: Level 1 Recall. Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class I recall of its ventilators,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dräger Medical Equipment (Shanghai) Co., Ltd. voluntarily recalls ventilators
- Company Name: Koo Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2017-02-21
- Product Name: Ventilator
- Recall Level: Level 1 Recall
- Recall Reason: The product may generate an error message indicating "potentiometer not connected/disconnected," triggering an audible and visual alarm, releasing pressure in the respiratory system, and stopping ventilation.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Koo Medical Equipment (Shanghai) Co., Ltd.
- Summary: Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class I recall of its ventilators, as reported by the National Medical Products Administration (NMPA) on February 21, 2017. The company discovered a critical safety issue where affected products could experience a "potentiometer not connected/disconnected" error. This malfunction triggers an audible and visual alarm, resulting in the release of pressure within the patient's respiratory system and a complete cessation of ventilation. A Class I recall signifies that there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. This serious defect directly impacts patient safety by potentially interrupting essential life support, creating a high risk for patients dependent on mechanical ventilation. Under the regulatory oversight of the NMPA, Dräger Medical Devices is undertaking this voluntary recall. The required action involves the removal of the affected ventilator models, specifications, and batches from the market, with comprehensive details provided in the "Medical Device Recall Event Report Form." This action is crucial to mitigate the significant health risks associated with the identified malfunction, ensuring patient safety and adherence to medical device standards.

Company: https://www.globalkeysolutions.net/companies/koo-medical-equipment-shanghai-co-ltd/629448d1-2f5c-4db0-8ac4-522b6d76800f/