Events

Rappel de Draeger Babytherm Infant Warmers

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Draegerwerk AG & Co KGaA.

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
    17302
  • Date de mise en oeuvre de l'événement
    2014-09-05
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • Cause
    The manufacturer is aware of a case in which a side panel on a babytherm 8010 did not fully slide to the bottom in the corner guide and was not completely locked. the side panel did not open during this incident and no patient was affected., furthermore, if the inner 70mm panels were not always used and if a side panel has not been fully locked into position this may allow the baby's movements to open the side panel - it may be possible for a child to fall out.
  • Action
    Manufacturer to issue advice regarding use

Device

Draeger Babytherm Infant Warmers

Manufacturer

Draegerwerk AG & Co KGaA