Events

Recall of BABYTHERM 8004/8010

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER MEDICAL CANADA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    92075
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Draegerwerk ag&co kgaa the parent company of draeger 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.

Device

BABYTHERM 8004/8010
  • Model / Serial
    Model Catalog: FR 00114 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FR 00098 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FR 00120 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    BABYTHERM 8004/8010
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.