Events

Rappel de Trilogy dual prescription ventilators with software versions 13.2.04, 13.2.05, 14.0.00, and 14.1.01

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia 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-2016-RN-00107-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-01-28
  • 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-2016-RN-00107-1
  • 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
    Philips respironics has become aware that trilogy ventilators with the affected software versions and dual therapy prescriptions are susceptible to an inadvertent change between prescriptions. this may occur under a particular set of operating conditions without requiring confirmation of the change by the user.- device connected to the ac power source- device software versions 13.2.04, 13.2.05, 14.0.0 or 14.1.01- dual prescription is on- menu access is limited- device powered on- the device is allowed to operate for 5 or more minutes without pressing the up arrow keypressing the right key selects the “switch to secondary settings” menu. pressing the right key again within the next 30 seconds, confirms the “switch to secondary settings” and the device will switch from the primary to the secondary settings. the devices continue to display the active prescription in the upper left hand corner of the display, however, the user may be unaware of this change.
  • Action
    Philips is advising users that there is a software update available (my.respironics.com) for users to upgrade the device software to version 14.1.02. This action has been closed out 01 Feb 2017.

Device

Trilogy dual prescription ventilators with software versions 13.2.04, 13.2.05, 14.0.00, and 14.1.01
  • Modèle / numéro de série
    Trilogy dual prescription ventilators with software versions 13.2.04, 13.2.05, 14.0.00, and 14.1.01Model Numbers: 100 and 202ARTG Numbers: 159490 and 174169
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA