Events

Retiro De Equipo (Recall) de FABIUS TIRO ANESTHESIA SYSTEM

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
    47692
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-08-08
  • 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
    Some units did not pass the high voltage final test during the final checking of the fabius in draeger production facility. investigations carried out revealed that on some power supply units from a particular batch the required minimum clearance bewteen an electrical component and the unit housing was not maintained. under the influence of mechanical forces (eg. movement of the device) this may result in small bypass currents flowing in the interior of the unit which in extreme cases cause failure of the automatic ventilation function of the device. when such faults occur the standard required manual ventilation is possible an acoustic alarm is generated and the indicators on the device flash.

Device

FABIUS TIRO ANESTHESIA SYSTEM
  • Modelo / Serial
    Model Catalog: 8606000 (Lot serial: >10 numbers contact mfg); Model Catalog: 8607000 (Lot serial: >10 numbers contact mfg)
  • Descripción del producto
    FABIUS TIRO
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

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