Events

Retiro De Equipo (Recall) de CARDIOHELP-I

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
    82612
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-09-04
  • 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
    In certain rare instances the cardiohelp-i device may display an error message with audible alarm indicating "battery defective". the alarm will occur while booting or when the main power supply is unplugged from the main power source. this is due to a defective capacitor within the battery manager board. further when alarming the hmi (human machine interface) will gradually become black due to the hmi back light shutting down. the defective capacitor behavior leads to the shutdown of the battery booster that boosts the voltage of the batteries from 12v to 24v. this in turn leads to the state that the voltage is insufficient to ignite the backlight of the display. blood flow is not affected during the shutdown time of the hmi therefore there is no risk of circulatory impairment.

Device

CARDIOHELP-I
  • Modelo / Serial
    Model Catalog: 70104.8012 (Lot serial: 90410704); Model Catalog: 70104.8012 (Lot serial: 90410486); Model Catalog: 70104.8012 (Lot serial: 90410493)
  • Descripción del producto
    CARDIOHELP-i
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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