Events

Rappel de LIFEPAK 1000 SYSTEM - DEFIBRILLATOR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PHYSIO-CONTROL CANADA SALES 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
    29790
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2017-01-13
  • 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
    Physio-control has received complaints that the lifepak 1000 defibrillator is unexpectedly powering off during device usage. this unexpected shut down is due to an intermittent connection between the battery and device contacts. a defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt which may expose patients to the risk of serious harm or death. this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. this has been observed to occur in devices that are exposed to vibration and have a battery installed for extended time without being removed from the lifepak 1000 for inspection and then reinstalled.

Device

LIFEPAK 1000 SYSTEM - DEFIBRILLATOR
  • Modèle / numéro de série
    Model Catalog: 99425-XXXXXX (Lot serial: > 1000 numbers contact mfg)
  • Description du dispositif
    LIFEPAK 1000 DEFIBRILLATOR
  • Manufacturer
    PHYSIO-CONTROL CANADA SALES LTD

Manufacturer

PHYSIO-CONTROL CANADA SALES LTD
  • Adresse du fabricant
    HAMILTON
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    HC