# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/air-liquide-medical-systems-sa/449fdcb2-d404-477b-9fef-603fbe78c9f2/
Source feed: China

> China NMPA product recall for Ventilator by Air Liquide Medical Systems S.A. published June 21, 2019. Recall level: Level 3 Recall. Air Liquide Medical Systems S.A., in cooperation with its agent Air Liquide Medical Supplies (Beijin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Air Liquide Medical Systems S.A. initiates voluntary recall of ventilators
- Company Name: Air Liquide Medical Systems S.A.
- Publication Date: 2019-06-21
- Product Name: Ventilator
- Recall Level: Level 3 Recall
- Recall Reason: When using a MONNAL T75 ventilator in a hospital setting, if the physician is using a pressure support ventilation mode (such as PSV, PSV-NIV, or PS-PRO) and the pressure support is set to 2 cmH2O, the user will be unable to increase the PEEP setting. This limitation persists even if the ventilation mode is subsequently changed. The inability to increase PEEP can lead to a risk of inadequate ventilation, which could potentially affect the patient. This software glitch is only triggered when the medical team changes the pressure support setting to 2 cmH2O, while the default setting is 10 cmH2O, which limits the frequency of the glitch.
- Discovering Company: Air Liquide Medical Supplies (Beijing) Co., Ltd.
- Manufacturing Company: Air Liquide Medical Systems S.A.
- Summary: Air Liquide Medical Systems S.A., in cooperation with its agent Air Liquide Medical Supplies (Beijing) Co., Ltd., initiated a voluntary Class III recall of its MONNAL T75 ventilators, as regulated by the National Medical Products Administration (NMPA). This recall, affecting 6,138 units globally, stems from a software malfunction identified in the device. The issue occurs when physicians utilize pressure support ventilation modes (PSV, PSV-NIV, or PS-PRO) and set the pressure support to 2 cmH2O. Under this specific condition, the ventilator prevents users from increasing the PEEP (Positive End-Expiratory Pressure) setting, a limitation that persists even after switching ventilation modes. This inability to properly adjust PEEP carries a risk of inadequate patient ventilation. However, the malfunction's frequency is limited as the default pressure support setting is 10 cmH2O, and no domestic complaints or adverse events have been reported. Corrective actions involve sending safety information notices to all users of the affected MONNAL T75 ventilators and performing necessary software upgrades on all impacted devices, without requiring equipment return.

Company: https://www.globalkeysolutions.net/companies/air-liquide-medical-systems-sa/cc2d56e7-705b-4102-85bb-ace16710dee2/