Events

Rappel de Dräger Carina Ventilator

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-00394-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-05-01
  • 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-00394-1
  • 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
    Draeger has been made aware that one component in the valve assembly of the carina ventilator was not sufficiently cleaned by a supplier. over time, this can result in the material of the valve assembly becoming corroded and can result in contamination of the breathing gas.This issue was identified during production at dräger. to date, no reports of adverse events have been received as a result of this issue.
  • Action
    Draeger is advising customers to remove the potentially affected devices from use immediately to exclude any further risk to patients. Draeger will provide affected sites with loan devices to alleviate any delays and/or downtime. Draeger will contact users (via Engineering Department) to schedule the replacement of the affected components.

Device

Dräger Carina Ventilator
  • Modèle / numéro de série
    Dräger Carina VentilatorSerial Numbers: ASKM-0074; ASKM-0075; ASKM-0076; ASKM-0077; ASKM-0078; ASKM-0079; ASKM-0080; ASKM-0082; ASKM-0083; ASKM-0084; ASKM-0085; ASKM-0086; ASKM-0087; and ASKM-0088ARTG Number: 140966(Draeger Australia - Ventilator, adult)
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd