Events

Rappel de LIFEPAK CR PLUS AED (SEMIAUTOMATIC OPERATION)

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par IRIDIA MEDICAL.

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
    17138
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-10-04
  • 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
    Physio-control has become aware of an issue whereby the lifepak cr plus aed or lifepak expressaed may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. physio-control has determined that there are presently 25178 devices in the field of which approximately 9600 may have this faulty component. a defibrillator in this condition is not delivered and a patient is not resuscitated. all reports received from customers have been noted during initial set up and testing of the device.

Device

LIFEPAK CR PLUS AED (SEMIAUTOMATIC OPERATION)
  • Modèle / numéro de série
    Model Catalog: 99403-000209 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80403-000280 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80403-000278 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 3202359-092 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 3202359-019 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 3200731-XXX (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 3202359-XXX (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 99403-000156 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 99427-000133 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 99427-000129 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80427-000156 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80427-000155 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80403-000279 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80403-000281 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 99403-000210 (Lot serial: > 1000
  • Description du dispositif
    LIFEPAK CR Plus (Semi-Automatic);LifepaK CR Express (Semi-Automatic Operation);LIFEPAK CR Express (Semi-Automatic Operation);LIFEPAK CR Plus (Fully Automatic)
  • Manufacturer
    IRIDIA MEDICAL

Manufacturer

IRIDIA MEDICAL