Events

Retiro De Equipo (Recall) de HEATER-COOLER UNIT HCU 40

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
    35779
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-07-01
  • 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 recently detected a leak in the water circuit of an hcu 40 during the final quality inspection. the investigation revealed that the leakage was caused by a damaged sealant in the water circuit. the damage occurred during device assembly and it cannot be ruled out with absolute certainty that hcu 40s in the field equipped with the same type of sealant could exhibit this failure too. the hcu 40 with the serial number 90440265 could potentially exhibit a leak in the water circuit. in case of water leakage a short circuit of an electrical component and device shut down are the potential consequences.

Device

HEATER-COOLER UNIT HCU 40
  • Modelo / Serial
    Model Catalog: 70105.4054 (200-240V) (Lot serial: 90440265)
  • Descripción del producto
    HEATER COOLER UNIT HCU 40
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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