Events

Rappel de Dräger Fabius Anaesthesia Machine Device's : Fabius Plus XL, Fabius Tiro, Fabius Tiro, Fabius GS Premium, Fabius Plus XL

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Draeger Australia Pty Ltd.

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
    RC-2018-RN-00158-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-02-27
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00158-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Dräger has become aware of one case where the automatic ventilation failed during the operation of a fabius unit. this was due to the motor moving beyond the upper position and thereby damaging the ventilator cover. ventilation of the patient could reportedly be continued by means of the manspont mode and a manual resuscitator.No serious injury has been reported to date.As a precaution drager will be updating relevant units.
  • Action
    Drager is advising they are currently producing replacement motors for the potentially affected devices. Dräger Service have ordered the replacement motor(s) and on receipt of the part from Germany, will contact the Biomedical Engineering team to arrange free of charge, the installation and testing of the replacement motor. In the interim, users may continue to operate the anaesthesia device with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for Use.

Device

Dräger Fabius Anaesthesia Machine Device's : Fabius Plus XL, Fabius Tiro, Fabius Tiro, Fabius GS ...
  • Modèle / numéro de série
    Dräger Fabius Anaesthesia MachineDevice's : Fabius Plus XL, Fabius Tiro, Fabius Tiro, Fabius GS Premium, Fabius Plus XLSerial Number's :ASKM-0047, ASKH-0027, ASKH-0168, ASKH-0140, ASKM-0246ARTG Number: 104223Draeger Australia - Anaesthesia system
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd