Events

Retiro De Equipo (Recall) de LAERDAL SILICONE RESUSCITATOR - ADULT BASIC

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

¿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
    44449
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2004-01-09
  • 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
    Ambulance arrived on the scene to a patient in cardiac arrest an attempt to resuscitate failed as the resuscitator failed to operate as intended. the patient died.

Device

LAERDAL SILICONE RESUSCITATOR - ADULT BASIC
  • Modelo / Serial
    Model Catalog: 87 00 55 (Lot serial: NUMBER 87 54 00.); Model Catalog: 87 00 53 (Lot serial: NUMBER 87 54 00.); Model Catalog: 87 00 52 (Lot serial: NUMBER 87 54 00.); Model Catalog: 87 00 51 (Lot serial: NUMBER 87 54 00.); Model Catalog: 87 00 50 (Lot serial: NUMBER 87 54 00.); Model Catalog: 87 00 55 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 87 00 53 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 87 00 52 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 87 00 51 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 87 00 50 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 85 00 50 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 85 00 55 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 86 00 55 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 86 00 53 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 86 00 52 (Lot serial: NUMBER 87 54 00.); Model Catalog: 86 00 51 (Lot serial: NUMBER 87 54 00.); Model Catalog: 86 00 50 (Lot
  • Descripción del producto
    LSR ADULT RESUSCITATOR AND UPGRADE KIT
  • Manufacturer
    LAERDAL MEDICAL CANADA LTD.

Manufacturer

LAERDAL MEDICAL CANADA LTD.
  • Dirección del fabricante
    TORONTO
  • Empresa matriz del fabricante (2017)
    Laerdal Invest AS
  • Source
    HC