Events

Rappel de Astral 100 and 150 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-2017-RN-00762-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-07-19
  • 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-2017-RN-00762-1
  • 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 has received a number of reports about the performance of the internal battery, where false activation of a fuse leads to shut down of the internal battery. prior to the issue occurring, one or more of the following alarms were activated: battery inoperable, power fault / no charging, device overheating. if the device is running on external power then ventilation will continue. if the device is not running on external power, or external power is removed, then ventilation will stop with activation of the total power fail alarm. reconnection to external power will enable ventilation to recommence.When ventilators use the internal battery as the sole power source, any performance issue with the battery could lead to cessation of therapy. in these cases, ventilator-dependent patients may be at risk if no urgent action is taken to restore power or switch to back-up ventilation. there have been no reports of this issue in australia to date, nor any adverse health effects.
  • Action
    ResMed is providing a Clinical Guide addendum that is to be kept with existing Clinical Guides that includes the following warning: The internal battery is NOT intended to serve as a primary power source. It should only be used briefly when necessary; for example, when changing power sources, or when other sources are temporarily unavailable. In addition, users and carers are to continue to follow all patient and device information in the Astral User and Clinical Guides, in particular the following warnings: - For ventilator-dependent patients, always have alternate ventilation equipment available, such as a back-up ventilator, manual resuscitator or similar device. Failure to do so may result in patient injury or death. - Ventilator-dependent patients should be continuously monitored by qualified personnel or adequately trained carers. These personnel and carers must be capable of taking the necessary corrective action in the event of a ventilator alarm or malfunction.

Device

Astral 100 and 150 ventilators
  • Modèle / numéro de série
    Astral 100 and 150 ventilatorsAll Astral External BatteriesAll Astral Battery PacksARTG Numbers: 219429 and 158756
  • Manufacturer
    Resmed Limited

Manufacturer

Resmed Limited