Events

Retiro De Equipo (Recall) de OXYLOG 3000 SYSTEM - DISPOSABLE VENTILATION HOSE

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
    27635
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-06-03
  • 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
    During the course of routine internal testing the firm detected isolated episodes of leakage at the check valve (one way valve of the inspiration branch) of the disposable pediatric ventilation hose of oxylog 3000 system and oxylog plus model 5704964. affected circuits with this fault were potentially distributed to customers. all other ventilation circuits for the oxylog family of devices are not affected. leakage at the check valve can result in patient's exhaled gas entering into the breathing circuit which could lead to the rebreathing of the same exhaled gas with reduced oxygen concentration/elevated co2 for the patient. this leakage is not detected during the ventilator operational readiness check.

Device

OXYLOG 3000 SYSTEM - DISPOSABLE VENTILATION HOSE
  • Modelo / Serial
    Model Catalog: 5704964 (Lot serial: MFG DATES
  • Descripción del producto
    OXYLOG 3000 SYSTEM - DISPOSABLE VENTILATION HOSE
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

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