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 Notice
to its customers in August 2014 but hasn’t had enough replies
to know if users have received and acted upon this information.
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 Notice (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.
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