Events

Rappel de LIFEPAK 20E 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
    134664
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-12-07
  • 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 is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. the symptoms of these failures may include unexpected power on and power off device lock-up or a failure to power on or off any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death. these failures are the result of manufacturing process residue located beneath a component mounted on the power printed circuit board assembly (pcba). there have been no adverse events reported as a result of this issue.

Device

LIFEPAK 20E DEFIBRILLATOR
  • Modèle / numéro de série
    Model Catalog: 70507-XXXXXX (Lot serial: > 10 numbers contact mfg.); Model Catalog: 99507-XXXXXX (Lot serial: > 10 numbers contact mfg.)
  • Description du dispositif
    LIFEPAK 20E DEFIBRILLATOR/MONITOR
  • Manufacturer
    PHYSIO-CONTROL CANADA SALES LTD

Manufacturer

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