Events

Rappel de CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MAQUET-DYNAMED INC..

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
    105383
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-04-05
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Maquet continually monitors the performance of the cardiosave iabps and has discovered four issues that could affect the cardiosave iabp performance and may cause the cardiosave iabp to not meet performance specifications. the scroll compressor may not meet the performance specifications for output pressure or vacuum at specific flow rates. due to an unintended increased size in the his/cis connectivity packet the interface may reject the packet due to increased packet size and the his/cis may not be able to provide external data communications of electronic medical records as intended. the cardiosave iabp may have intermittent connectivity issues causing display blanking followed by a "system failure" audible alarm and shut down. during operation the cardiosave iabp may shutdown due to a short on the video generator board. intermittent connection with the cardiosave pneumatic module connector may result in iabp startup failure and/or iabp shutdown.

Device

CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP
  • Modèle / numéro de série
    Model Catalog: 0998-00-0800-53 (Lot serial: > 10 NUMBERS CONTACT MFG)
  • Description du dispositif
    CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    HC