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.
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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.