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 WORKPLACE MEDICAL FIRST AID TRAINING.

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
    25380
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-02-12
  • 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 become aware of incidents where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. a defibrillator in this scenario has the potential to fail to deliver a shock with the potential result that therapy is not delivered and a patient is not resuscitated. we have learned this to be as a result of batteries not being replaced when they have reached a low or very low state of charge as indicated in the readiness display on the device.

Device

LIFEPAK 1000 SYSTEM - DEFIBRILLATOR
  • Modèle / numéro de série
    Model Catalog: 99425-XXXXXX (Lot serial: all lots. contact mfg.)
  • Description du dispositif
    LIFEPAK 1000 SYSTEM - DEFIBRILLATOR
  • Manufacturer
    WORKPLACE MEDICAL FIRST AID TRAINING

Manufacturer

WORKPLACE MEDICAL FIRST AID TRAINING
  • Adresse du fabricant
    HAMILTON
  • Source
    HC