Events

Retiro De Equipo (Recall) de HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT VARIOUS VOLTAGES

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MAQUET-DYNAMED 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
    30584
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-10-22
  • 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
    Maquet cardiopulmonary has received complaints associated with a failure of the power supply board of the hcu 30. an internal investigation showed that a drop of more than 10% voltage can cause an overheating and subsequent failing of the ntc (negative temperature coefficient) r56 thermistor of the power supply board. this failure typically occurs when the compressor is switched on i.E. before patient connection. a defective thermistor results in an inoperable compressor or in an inoperable hcu 30. there are no complaints reported associated with a patient injury or death.

Device

HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT VARIOUS VOLTAGES
  • Modelo / Serial
    Model Catalog: 00939001 (Lot serial: > 10 numbers contact mfg); Model Catalog: 00705501 (Lot serial: > 10 numbers contact mfg); Model Catalog: 0704629 (Lot serial: > 10 numbers contact mfg)
  • Descripción del producto
    HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    HC