Events

Retiro De Equipo (Recall) de ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM - MODEL 5000 CONTROL MODULE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BARD 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
    52235
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-08-28
  • 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
    This recall is being initiated by bard canada in order to inform users of a safety concern while using temperature simulator keys with the arctic sun temperature management system. two adverse events have been reported to bard medical division. in each instance a temperature simulator key (product code 748-00 and as part of service kit 771-00) was connected to the patient temperature cable instead of the patient temperature probe. due to the false patient temperature reading from the temperature simulator key improper targeted temperature therapy was delivered to the patients.

Device

ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM - MODEL 5000 CONTROL MODULE
  • Modelo / Serial
    Model Catalog: 5000-00-00 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 2000-02 (Lot serial: ALL SERIAL NUMBERS)
  • Descripción del producto
    ARCTIC SUN TEMP MANAGEMENT SYSTEM 5000
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.