Events

Rappel de eVent Medical Inspiration LS & i Series Ventilator Systems

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia.

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-2015-RN-01059-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-10-28
  • 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-2015-RN-01059-1
  • 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
    Investigations have identified that a component on the systems power board can fail in a manner which can cause the ventilator to shut down without the alarm being triggered. this failure could result in death or serious injury to a patient.
  • Action
    Users should discontinue use of the affected ventilators immediately until correction is completed. The manufacturer, eVent Medical has identified a correction to this issue which requires removal of the potentially faulty component from the power board. The corrective action will be undertaken by Taleb Medical during the month of November 2015. This action has been closed-out on 17/08/2016.

Device

eVent Medical Inspiration LS & i Series Ventilator Systems

Manufacturer

The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia