MHRA Medical Device Alert : Babytherm infant warmers and open infant care units for newborns manufactured by Draeger Medical...

Babytherm infant warmers and open infant care units for newborns.
Manufactured by Draeger Medical.
Model numbers: 8004, 8010 and 8000WB.
This device is an open care unit for warming premature babies, neonates and infants with a body weight of up to 8 kg.
Risk of baby falling out of the device.
Failure to follow the instructions for use for inserting the inner safety panels and locking the outer safety side panels may result in them opening unexpectedly.
Draeger sent a Field Safety NoticePDF file (opens in new window) to its customers in August 2014 but hasn’t had enough replies to know if users have received and acted upon this information.
  • Identify affected devices.
  • Ensure users read the important information in the Field Safety NoticePDF file (opens in new window) (FSN) and follow the instructions (see appendix) to ensure that the inner safety panels are in place and the outer side panels are securely locked into position.
  • If the locking mechanism is not functioning, contact Draeger.
  • Complete the acknowledgement sheet you received with the FSN and return it to Draeger.

Action by

All those who use these devices.

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