FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

UK Sends Out Safety Alerts for Infant Warmers, Ventilators

Aug. 11, 2016
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The UK’s Medicines and Healthcare products Regulatory Agency issued safety warnings on two pediatric products manufactured by Germany’s Dragerwerk AG & Co.

A risk of a heating element overheating and releasing hot particles that could result in fire triggered the MHRA to issue warnings on Dragerwerk’s Babytherm infant warmer.

The agency alerted healthcare professionals that the infant warmer poses a fire risk in skin temperature mode. The action affects the Babytherm 8004/8010 infant warmer. Healthcare professionals were advised to use the manual mode rather than the skin-temperature mode to avoid risk. — Tamra Sami

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