Events

Rappel de BABYTHERM 8004/8010

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par DRAEGER MEDICAL CANADA INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    92075
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-06-27
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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)
  • Description du dispositif
    BABYTHERM 8004/8010
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.