Events

Rappel de SAMARITAN PAD AUTOMATED EXTERNAL DEFIBRILLATOR(AED)- MAIN UNIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par RESCUE 7 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
    102713
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-11-19
  • 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
    Devices within these serial number ranges may be affected by one of both of these 2 identified. issue one: devices may intermittently or sometimes repeatedly switch themselves on and remain on for 10minutes which could eventually cause premature depletion of battery capacity. should this condition not be detected the battery may become depleted below a level where it could power the device to safely deliver therapy if required. issue two: the battery management software in affected devices may mis-interpret changes in voltage which occur during the normal operation of the device as indications of a low battery capacity. this can trigger an unnecessary low battery warning which if it occurs during an rescue event may cause the device to switch off and/or may delay the delivery of shock therapy.

Device

SAMARITAN PAD AUTOMATED EXTERNAL DEFIBRILLATOR(AED)- MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: SAM-300 (Lot serial: 10C00200000 - 10C00210106); Model Catalog: SAM-300 (Lot serial: 040000501 - 0700032917); Model Catalog: SAM-300 (Lot serial: 08A00035000 - 10A0070753); Model Catalog: SAM300P (Lot serial: 040000501 - 0700032917); Model Catalog: SAM300P (Lot serial: 10C00200000 - 10C00210106); Model Catalog: SAM300P (Lot serial: 08A00035000 - 10A0070753)
  • Description du dispositif
    samaritan PAD SAM 300/300P
  • Manufacturer
    RESCUE 7 INC.

Manufacturer

RESCUE 7 INC.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Rescue 7 Inc
  • Source
    HC