Events

Retiro De Equipo (Recall) de INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE - BABYLOG VN500

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por DRAEGER MEDICAL 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
    22631
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-12-23
  • 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
    Drager had been informed about one case in which the neonatal patient was not adequately ventilated in high frequency oscillation (hfo) ventilation mode. the patient desaturated no permanent patient injury occured. investigations have shown that the instability of the mean airway pressure caused insufficient gas exchange resulting in the desaturation of the patient.

Device

INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE - BABYLOG VN500
  • Modelo / Serial
    Model Catalog: 8415000 (Lot serial: ASBL-0049); Model Catalog: 8415000 (Lot serial: ASBL-0035); Model Catalog: 8415000 (Lot serial: ASBL-0034); Model Catalog: 8415000 (Lot serial: ASBL-0033); Model Catalog: 8415000 (Lot serial: ASBL-0065); Model Catalog: 8415000 (Lot serial: ASBL-0067); Model Catalog: 8415000 (Lot serial: ASBL-0064); Model Catalog: 8415000 (Lot serial: ASBL-0066); Model Catalog: 8415000 (Lot serial: ASBL-0045); Model Catalog: 8415000 (Lot serial: ASBL-0043); Model Catalog: 8415000 (Lot serial: ASBL-0050); Model Catalog: 8415000 (Lot serial: ASBL-0046); Model Catalog: 8415000 (Lot serial: ASBL-0044); Model Catalog: 8415000 (Lot serial: ASBL-0051); Model Catalog: 8415000 (Lot serial: ASBL-0039); Model Catalog: 8415000 (Lot serial: ASBL-0037); Model Catalog: 8415000 (Lot serial: ASBL-0040); Model Catalog: 8415000 (Lot serial: ASBL-0042); Model Catalog: 8415000 (Lot serial: ASBL-0047); Model Catalog: 8415000 (Lot serial: ASBL-0041); Model Catalog: 8415000 (Lot serial: ASBL-0038); Model Catalog:
  • Descripción del producto
    VENTILATION NEONATAL UNIT
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Stefan Dräger GmbH
  • Source
    HC