# China NMPA Product Recall - Baby radiant warmer

Source: https://www.globalkeysolutions.net/records/china_product_recall/draegerwerk-ag-co-kgaa/16b66963-1438-4b6c-bc3f-03066ec8962d/
Source feed: China

> China NMPA product recall for Baby radiant warmer by Draegerwerk AG & Co. KGaA published August 30, 2016. Recall level: Level II. Dräger Medical Devices (Shanghai) Co., Ltd. initiated a Level II voluntary recall, reported on June 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dräger Medical Equipment (Shanghai) Co., Ltd. has initiated a voluntary recall of infant radiant warmers.
- Company Name: Draegerwerk AG & Co. KGaA
- Publication Date: 2016-08-30
- Product Name: Baby radiant warmer
- Recall Level: Level II
- Recall Reason: Dräger has received individual reports that the Babytherm 8004 was incorrectly set to skin temperature mode for preheating in the absence of a patient. In skin temperature mode, the radiant heater's output is automatically controlled until the set skin temperature is reached. Because the temperature sensor is not actually in contact with the patient, the radiant heater remains at a high output power. Sustained high power output accelerates the aging of the heating element. If a component detaches from the heating element and falls onto the mattress, there is a risk of igniting towels on it. Our investigation revealed that our user manual did not contain clear indications or warnings about this malfunction. Furthermore, our analysis found that customers were not replacing the heating element regularly as instructed in the manual.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Draegerwerk AG & Co. KGaA
- Summary: Dräger Medical Devices (Shanghai) Co., Ltd. initiated a Level II voluntary recall, reported on June 29, 2016, and published by the National Medical Products Administration (NMPA) on August 30, 2016, for its Infant Radiant Warmers, specifically models Babytherm 8004 and 8010. This recall, affecting 657 units in China, addresses a significant safety concern identified by the company. The main issue arises when the warmers are inadvertently operated in skin temperature mode for preheating without a patient present. In this scenario, the absence of a patient temperature sensor contact causes the radiant heater to maintain a continuously high power output. This sustained high power accelerates the aging of the heating element, posing a serious risk: parts may detach and fall onto the mattress, potentially igniting towels placed there. Dräger's investigation further revealed a deficiency in the product's user manual, which failed to provide clear warnings about this specific misoperation. Additionally, non-compliance with recommended regular heating element replacement by users contributed to the issue. As required actions under the NMPA framework, Dräger is implementing preventive measures, including the distribution of safety notices and updated instruction manuals to customers, offering essential guidance and warnings to mitigate this fire hazard and ensure safer product use.

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