# China NMPA Product Recall - Ventilator (Monnal T50)

Source: https://www.globalkeysolutions.net/records/china_product_recall/air-liquide-medical-systems-sa/0ea06e13-e292-4291-b2e1-67105322677d/
Source feed: China

> China NMPA product recall for Ventilator (Monnal T50) by Air Liquide Medical Systems S.A. published July 18, 2017. Recall level: Level 2 Recall. Air Liquide Medical Systems S.A., through its agent Air Liquide Medical Supplies (Beijing) Co., Ltd.

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Air Liquide Medical Systems S.A. initiates ventilator recall
- Company Name: Air Liquide Medical Systems S.A.
- Publication Date: 2017-07-18
- Product Name: Ventilator (Monnal T50)
- Recall Level: Level 2 Recall
- Recall Reason: The manufacturer discovered a defect in the power board of ventilators with serial numbers prior to MT50-04540, which could cause an unexpected loss of 5V voltage, resulting in the machine suddenly shutting down automatically; and the manufacturer also discovered that improper use of the built-in battery by overseas home users caused a sharp decrease in the effective battery charge, resulting in the machine suddenly shutting down automatically (when using only the built-in battery).
- Discovering Company: Air Liquide Medical Supplies (Beijing) Co., Ltd.
- Manufacturing Company: Air Liquide Medical Systems S.A.
- Summary: Air Liquide Medical Systems S.A., through its agent Air Liquide Medical Supplies (Beijing) Co., Ltd., initiated a Level II voluntary recall of certain ventilators (CFDA (Imported) No. 20143530589). This action, reported on June 19, 2017, and published by the National Medical Products Administration (NMPA) on July 18, 2017, addresses two critical issues. The primary concern is a defect in the power board of ventilators with serial numbers preceding MT50-04540. This flaw can lead to an unexpected loss of 5V voltage, causing the device to suddenly shut down. Additionally, the manufacturer identified that improper use of the built-in battery by overseas home users could result in a significant drop in effective battery charge, leading to an abrupt shutdown when operating solely on battery power. Globally, 4267 units were affected, with 7 units identified in China. Under NMPA regulations, the company is implementing several corrective actions. These include immediately instructing six affected hospitals to cease using the identified ventilators, offering backup devices, and issuing a nationwide reminder to all hospitals utilizing this ventilator model to diligently monitor and timely charge batteries. Furthermore, external alarm devices are being provided to the six affected hospitals. These alarms will activate upon unexpected shutdown, alerting users to take immediate action to maintain patient ventilation. The company also committed to implementing the manufacturer's final solution for these hospitals promptly upon its release.

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