Events

Rappel de Astral Ventilators - ResMed Astral 100 & Astral 150 with SR1.1 software (SX544-0301)

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-2016-RN-00050-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-18
  • 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-2016-RN-00050-2
  • 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
    Astral devices may experience an issue when powered by an external battery (astral external battery or rps ii). the issue can prevent the user from powering on the device after the auto power off feature powers off the device when there has been no user interaction with the device for 15 minutes and the ventilator is in stand-by.The external battery start up issue only affects astral 100 and astral 150 devices with sr1.1 software (sx544-0301).
  • Action
    ResMed is advising users to contact ResMed technical support to arrange for the installation of a software upgrade which will address the reported issue. Please note that this software upgrade (SX544-0401) addresses the circuit disconnection alarm issue reported previously (RC-2015-RN-00391-1) as well as the external battery power issue reported in this current recall notification. This action has been closed-out on 05/09/2016.

Device

Astral Ventilators - ResMed Astral 100 & Astral 150 with SR1.1 software (SX544-0301)
  • Modèle / numéro de série
    Astral Ventilators - ResMed Astral 100 & Astral 150 with SR1.1 software (SX544-0301)Product Codes 27081 and 27083ARTG Number: 219429
  • Manufacturer
    Resmed Limited

Manufacturer

Resmed Limited