Events

Rappel de EDWARDS EV1000 SYSTEM - VOLUMEVIEW THERMODILUTION CABLE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par EDWARDS LIFESCIENCES (CANADA) 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
    152782
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-05-26
  • 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
    Edwards lifesciences has initiated a voluntary safety alert regarding the ev1000a system to reinforce the proper set up of the external power supply according to the equipment's operator manual. the company received a recent event of an electrical fire therefore is sending a notice to all customers with ev1000a systems installed to confirm installation against the current requirements documented in the operator's manual section ev1000 power adapter mounting bracket.

Device

EDWARDS EV1000 SYSTEM - VOLUMEVIEW THERMODILUTION CABLE
  • Modèle / numéro de série
    Model Catalog: EVVVTC1 (Lot serial: ALL); Model Catalog: EVPSA1 (Lot serial: ALL); Model Catalog: EV1000A (Lot serial: ALL); Model Catalog: EVDBB1 (Lot serial: ALL); Model Catalog: EVFTC1 (Lot serial: ALL); Model Catalog: EVFTCL (Lot serial: ALL); Model Catalog: EVEC1 (Lot serial: ALL); Model Catalog: EVECL (Lot serial: ALL); Model Catalog: EVDBA1 (Lot serial: ALL); Model Catalog: EVPCA1 (Lot serial: ALL)
  • Description du dispositif
    EDWARDS EV1000 SYSTEM - VOLUMEVIEW THERMODIULTION CABLE;EDWARDS EV1000 SYSTEM - BIFURCATED POWER SUPPLY;EDWARDS EV1000 SYSTEM - MONITOR;EDWARDS EV1000 SYSTEM - FLOTRAC CABLE;EDWARDS EV1000 SYSTEM - ETHERNET CABLE;EDWARDS EV1000 SYSTEM - POWER ADAPTER;EDWA
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.