Events

Rappel de Astral 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 Resmed Limited.

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-00391-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-05-12
  • 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-00391-1
  • 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
    Resmed received an incident report involving circuit disconnection of a patient in a hospital where the device alarms did not operate because all alarms had been disengaged by the physician and the patient required medical intervention.
  • Action
    ResMed advises that, as long as the disconnection alarm is not disabled for high-dependency patients who are using the device continuously, as directed in the Instructions for Use, the above safety concern will not occur. Alarm configurations can only be changed by health professionals and cannot be modified by the patient in the home. ResMed intends to release and install an updated version of Astral software, in three months’ time, in which the circuit disconnection alarm for all ventilation modes for dependent patients cannot be deactivated. For more details, please see https://www.tga.gov.au/alert/astral-100-and-astral-150-ventilators. This action has been closed-out on 05/09/2016.

Device

Astral Ventilators
  • Modèle / numéro de série
    Astral VentilatorsAstral 100Model No: 27081Astral 150Model No: 27083ARTG Number: 219429
  • Manufacturer
    Resmed Limited

Manufacturer

Resmed Limited