Events

Retiro De Equipo (Recall) de EDWARDS EV1000 SYSTEM - VOLUMEVIEW THERMODILUTION CABLE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por EDWARDS LIFESCIENCES (CANADA) INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    152782
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-05-26
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    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)
  • Descripción del producto
    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.