BABYTHERM 8004/8010 (2016-06-27)

Starting date:

June 27, 2016

Posting date:

July 22, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-59464

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  Reason
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  Affected products

Affected products

A. BABYTHERM 8004/8010

Reason

Dragerwerk AG & Co. KGaA, the parent company of Drager Medical Canada Inc., became aware of a case in which a Babytherm 8004 open care warmer was operated in skin temperature mode with skin temperature sensor to prepare it for use. There was no patient in the warmer at the time. In skin temperature mode, the radiant warmer output is controlled automatically until the set skin temperature is reached. As a result of operating the temperature sensor without patient contact, the radiant warmer was operated continuously at a high output level. During this forced continuous operation under high thermal load, the heating element aged faster. As a result, a piece of the heating element detached and fell onto the mattress tray where a towel ignited. There were no reported injuries.

Affected products