Events

Rappel de CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Maquet Australia 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-00281-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-03-28
  • 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-2013-RN-00281-1
  • 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
    1 - there have been reported cases of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touchscreen) of the cardiohelp device. all manual settings are lost and the system will revert back to the original clinical settings.2 - through internal testing, it has been determined that there is a possibility that electromagnetic interference due to electric current fluctuations may cause pressure valves on the display to "freeze".
  • Action
    Maquet is providing work around instructions to prevent risk of injury to the patient in the unlikely event of the failure mode occurring during use. Maquet has updated its current CARDIOHELP-i software to version 3.3.2.0 and this will be installed by an authorised Maquet service technician.

Device

CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system)
  • Modèle / numéro de série
    CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system)Serial Number: All devices up to 90410628 excluding S/N 90410622 and 90410626ARTG Number: 179014
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA