Events

Rappel de Drager Oxylog Transport Ventilator

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
    19613
  • Date de mise en oeuvre de l'événement
    2016-01-13
  • 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
    In the course of product monitoring, some cases have been reported in which the "poti unplugged" error message was generated. in those cases an audible and visual alarm is generated, the breathing system releases pressure and the ventilation function stops operating., no patient injury has been reported due to this issue., the error message is caused by increased electrical contact resistances of the controllers (setting potentiometers). the increased resistance is caused by an oxide layer formed on the controller over a lengthy period of time. the oxide layer can only form if the controllers are rarely or never moved and according to our product monitoring, some users never, or rarely, use the fio2 controller.
  • Action
    Manufacturer to issue advice regarding use

Device

Drager Oxylog Transport Ventilator

Manufacturer

Draegerwerk AG & Co KGaA