# China NMPA Product Recall - Puritan Bennett™ 840 Ventilation System

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/aad06aee-b17f-4a08-aebf-80dd82d47564/
Source feed: China

> China NMPA product recall for Puritan Bennett™ 840 Ventilation System by Covidien llc published January 28, 2014. Recall level: . Covidien LLC, a U.S.-based manufacturer, initiated a voluntary global recall of its Puritan Bennett™

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien LLC, a US company, has recalled its ventilators.
- Company Name: Covidien llc
- Publication Date: 2014-01-28
- Product Name: Puritan Bennett™ 840 Ventilation System
- Recall Reason: The diagnostic code XB0069 indicates that the device will stop mechanical ventilation when there is an error in certain software versions.
- Discovering Company: Covidien Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: Covidien LLC, a U.S.-based manufacturer, initiated a voluntary global recall of its Puritan Bennett™ 840 Ventilator System. This action was reported by the Shanghai Municipal Food and Drug Administration on January 14, 2014, and subsequently publicized by the National Medical Products Administration (NMPA) on January 28, 2014. The recall stems from a rare software error that can cause the ventilator to cease mechanical ventilation under specific conditions, such as strong spontaneous breathing with high expiratory flow rates or when operating in volume control mode with extended inspiratory time and enabled leak compensation.

Upon malfunction, the device triggers high-priority visual and audible alarms, displays a "Device Warning," and illuminates indicators for "Exhaust Stopped" and "Safety Valve Open," enabling the patient to attempt independent breathing. While no incidents were reported in Asia at the time, the potential for interruption of assisted breathing prompted the recall. Covidien has developed an updated software solution to address this issue.

The required action involves Covidien implementing on-site corrective measures by installing the updated software on all affected ventilator units. Globally, 4,672 units are impacted, with 4,039 identified in Chinese hospitals. The NMPA has instructed all provincial Food and Drug Administrations to strengthen their oversight and management of these products.

Company: https://www.globalkeysolutions.net/companies/covidien-llc/5111c5da-0a3d-4895-b59e-e49f0ad3547d/