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.
The agency also issued safety alerts for a Draeger Medical pediatric ventilator due to a risk of rebreathing exhaled gases.
The alert affects the VentStar Oxylog3000F (P) 190 disposable pediatric ventilation circuit. Healthcare professionals were advised to return ventilation circuits manufactured up to and including March 2016, because they may leak at the check valve.
Read the safety alerts here: www.fdanews.com/08-04-16-ventilatoralert.pdf. — Tamra Sami