Events

Rappel de V60 Non-invasive Ventilators

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Mayo Healthcare 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-00625-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-06-18
  • 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-00625-1
  • 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
    In the rare even a component fails due to a software issue, the following sequence of events may occur:1) power management board assembly (pmba) vmain shorts to ground,2) the ventilator shuts down,3) the software repeatedly cycles through part of its initialisation sequence and power on self test (post), the alarm may not sound to indicate that ventilation therapy has ceased.
  • Action
    The V60 ventilator may continue to be used in accordance with its directions for use. A Mayo healthcare representative will be contacting users to schedule the corrective action to upgrade the software. A loan unit will be provided to the users until the corrective action is completed.

Device

V60 Non-invasive Ventilators

Manufacturer

Mayo Healthcare Pty Ltd