Events

Rappel de Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Distributed from 6 March 2012 to 31 December 2015

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-2016-RN-00460-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-04-22
  • 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-00460-1
  • 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
    Issues have been identified regarding the video display cables, video display assembly (internal pc board) and the pneumatic assembly for certain cardiosave hybrid and rescue iabps.1 - the cardiosave iabp may have intermittent connectivity issues with the video display cables causing display blanking followed by a “system failure” audible alarm and shut down.2 - the cardiosave iabp video display assembly may shutdown during operation due to a short on the video generator board.3 - intermittent connection with the cardiosave pneumatic module connector resulting in iabp startup failure and/or iabp shutdown.To date, there has been no reported patient harm or adverse events attributable to these issues.
  • Action
    Maquet is advising users to ensure an alternative device is available at all times as a backup, and that the affected units should not be used during ground or air transport. Maquet will be performing an on-site service to correct the reported issues. This action has been closed-out on 23/01/2017.

Device

Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Distributed from 6 Marc...
  • Modèle / numéro de série
    Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)Distributed from 6 March 2012 to 31 December 2015ARTG Number: 118266
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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