# China NMPA Product Recall - Emergency ventilator Oxylog 3000, Oxylog 3000 Plus

Source: https://www.globalkeysolutions.net/records/china_product_recall/draegerwerk-ag-co-kgaa/2876ffce-0a2e-4438-803c-babd1f2961de/
Source feed: China

> China NMPA product recall for Emergency ventilator Oxylog 3000, Oxylog 3000 Plus by Draegerwerk AG & Co. KGaA published March 01, 2017. Recall level: Class I Recall. Dräger Medical Devices (Shanghai) Co., Ltd., under the purview of the National Medical Products Admi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dräger Medical Equipment (Shanghai) Co., Ltd. voluntarily recalls ventilators
- Company Name: Draegerwerk AG & Co. KGaA
- Publication Date: 2017-03-01
- Product Name: Emergency ventilator Oxylog 3000, Oxylog 3000 Plus
- Recall Level: Class I Recall
- Recall Reason: Dräger has discovered that its Oxylog 3000 and Oxylog 3000 Plus systems can generate a "potentiometer not connected/disconnected" error message. In such incidents, an audible and visual alarm is triggered, the respiratory system releases pressure, and the ventilation mode stops supplying air to the patient. No injuries have been reported in any of these cases.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Draegerwerk AG & Co. KGaA
- Summary: Dräger Medical Devices (Shanghai) Co., Ltd., under the purview of the National Medical Products Administration (NMPA), initiated a Class I voluntary recall for its Oxylog 3000 and Oxylog 3000 Plus emergency and transport ventilators. Published on March 1, 2017, the recall addresses a critical safety concern: affected devices may produce a "potentiometer not connected/disconnected" error. This malfunction triggers an audible and visual alarm, leading to pressure release in the respiratory system and a complete stop of ventilation, posing a serious risk to patients. No injuries have been reported related to this issue. The regulatory framework for this recall is aligned with Chinese medical device standards, indicated by the CFDA and imported medical device registration numbers. Dräger's required corrective actions include issuing safety notices to all relevant customers, deploying maintenance personnel to upgrade the ventilator system software, and providing supplementary instruction manual pages to ensure comprehensive user information.

Company: https://www.globalkeysolutions.net/companies/draegerwerk-ag-co-kgaa/14744193-3c0e-42ad-b561-ad95278db9af/