Events

Rappel de Fabius Anaesthesia Machine

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 Medical 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-2013-RN-00835-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-08
  • 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-2013-RN-00835-1
  • 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
    Some units did not pass the high voltage test during the final checking of the fabius by the manufacturer. investigations carried out revealed that on some power supply units, the required minimum clearance between an electrical component and the unit housing was not maintained. under the influence of mechanical forces (e.G., movement of the device), this may result in small bypass currents flowing in the interior of the unit which in extreme cases cause failure of the automatic ventilation function of the device. when such faults occur, the standard required manual ventilation is possible, an acoustic alarm is generated and the indicators on the device flash.
  • Action
    As an interim measure, Draeger Medical is advising users to switch over to manual ventilation mode should users experience a failure of the automatic ventilation function. The power supply units will be replaced as a permanent correction.

Device

Fabius Anaesthesia Machine
  • Modèle / numéro de série
    Fabius Anaesthesia MachineSupplied between February to July 2013Serial Number: ASEC-0203ARTG Number: 104223
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd