Events

Rappel de BABYTHERM 8000 LDR WARMING BED

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
    26564
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-08-25
  • 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
    As part of draeger's market and product monitoring they have become aware of a case in which a side panel on a babytherm 8010 did not fully slide to the bottom in the corner guides and was not completely locked. the side panel did not open during this incident and no patient was affected. when reviewing the locking mechanism in a number of hospitals it was possible to fully close the side panels by pushing down on them slightly. however it cannot be guaranteed that the panel will lock into position under its own wieght.

Device

BABYTHERM 8000 LDR WARMING BED
  • Modèle / numéro de série
    Model Catalog: FR00050 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FR 00120 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FR 00098 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FR 00114 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    BABYTHERM 8000 LDR WARMING BED
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.