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
    103412
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-02-04
  • 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
    Since the commencement of commercialization of the cardiosave hybrid intra-aortic balloon pumps (iabp) in december 2011 maquet has received thirteen (13) power supply complaints that were determined to be related to suboptimal thermal management. it is important to note that none of the thirteen complaints identified any adverse patient events. suboptimal thermal management of the power supply may result in the power supply not providing the correct output voltage to the cardiosave hybrid iabp console and the inability to charge the batteries. failure to provide the correct output voltage to the console will result in the unit not functioning from ac power even when plugged into an active electrical outlet. should a power supply malfunction occur an on screen message will alert the healthcare provider that the cardiosave hybrid iabp unit is operating on battery power.

Device

CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP
  • Modèle / numéro de série
    Model Catalog: 0998-00-0800-XX (Lot serial: CA221162L2); Model Catalog: 0998-00-0800-XX (Lot serial: CA222640A3); Model Catalog: 0998-00-0800-XX (Lot serial: CA216325I2); Model Catalog: 0998-00-0800-XX (Lot serial: CA237421K3); Model Catalog: 0998-00-0800-XX (Lot serial: CA221164L2)
  • Description du dispositif
    MAQUET CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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