Events

Rappel de Drager D-Vapor

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
    20020
  • Date de mise en oeuvre de l'événement
    2016-04-19
  • 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
    As part of our continued market and product monitoring we have become aware of isolated cases in which the unwanted release of evaporating agent was observed by users at the end of the filling procedure. the release may lead to spraying of aerosol into face and eyes of the operator. eye contact with volatile anaesthetics can result in serious irritation; immediate flushing of eyes and consultation of a physician is recommended. recently updated material safety data sheets (msds) of desflurane manufacturers recommend the wearing of safety glasses when handling these substances.
  • Action
    Instructions for use to be updated

Device

Drager D-Vapor
  • Modèle / numéro de série
    Model: drager D Vapor, Drager D Vapor 300, Affected:
  • Manufacturer
    Draegerwerk AG & Co KGaA

Manufacturer

Draegerwerk AG & Co KGaA