Events

Retiro De Equipo (Recall) de OXYLOG 3000 SYSTEM - MAIN UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por DRAEGERWERK AG & CO. KGAA.

¿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
    152191
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-12-23
  • 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
    Draeger has become aware of situations where the error message "poti unplugged" was generated. in these cases an acoustic and visual alarm is generated the breathing system releases pressure and the ventilation function stops operating. draeger's investigation showed that the error message is caused by increased electrical contact resistance of the controllers (adjustment potentiometers). the increased resistance is the result of an oxide layer on the controllers which accumulates over a long period of time. this oxide layer can only accumulate if the controllers are moved rarely or never. draeger's product monitoring has shown that some users rarely use the controller or do not use it at all.

Device

OXYLOG 3000 SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: 2M86955 (Lot serial: ALL); Model Catalog: 5704811 (Lot serial: ALL); Model Catalog: 5705081 (Lot serial: ALL)
  • Descripción del producto
    OXYLOG 3000
  • Manufacturer
    DRAEGERWERK AG & CO. KGAA

Manufacturer

DRAEGERWERK AG & CO. KGAA