# China NMPA Product Recall - Anesthesia machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/maquet-critical-care-ab/3ccdaae9-e4b9-44ea-ab93-c07a9a98ae7b/
Source feed: China

> China NMPA product recall for Anesthesia machine by Maquet Critical Care AB published August 28, 2016. Recall level: Level II. Maikewei (Shanghai) Medical Equipment Co., Ltd., the Chinese responsible unit for Maquet Critical Ca

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maikewei (Shanghai) Medical Equipment Co., Ltd. voluntarily recalls anesthesia machines
- Company Name: Maquet Critical Care AB
- Publication Date: 2016-08-28
- Product Name: Anesthesia machine
- Recall Level: Level II
- Recall Reason: The manufacturer discovered that the switches for the external oxygen supply and the suction module sometimes failed to activate, causing the suction function to malfunction.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Maquet Critical Care AB
- Summary: Maikewei (Shanghai) Medical Equipment Co., Ltd., the Chinese responsible unit for Maquet Critical Care AB, initiated a Class II medical device recall, publicly announced on August 28, 2016. The recall pertains to specific Anesthesia Machine models, specifically their external oxygen and suction modules. The issue, identified by the manufacturer and reported on May 6, 2016, is a potential failure of the module's switch to activate, leading to a suction malfunction. While the external oxygen component remains operational, the inability to provide suction poses a patient safety risk, as it could impede the clearance of fluids from a patient's airway. Fortunately, no patient injuries related to this defect have been reported.

Under the guidance of the National Medical Products Administration (NMPA) and referencing the CFDA (Imported) No. 20123542189 registration, Maikewei (Shanghai) Medical Equipment Co., Ltd. is undertaking two primary corrective actions. First, the company is distributing a "Medical Device Recall Notice" to all customers using the affected products. Second, to resolve the defect and ensure patient safety, they are providing a free replacement of the faulty external oxygen suction modules with an improved version. This action is global in scope, despite only one affected unit being imported and sold in China.

Company: https://www.globalkeysolutions.net/companies/maquet-critical-care-ab/aa5a1d63-4746-4f71-97ad-6b24c8cc7ad5/