Events

Retiro De Equipo (Recall) de CARDIOHELP-I (Heart-lung bypass system)Serial numbers affected: 90140472, 901404544, 90410553ARTG Number: 179104

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet Australia Pty Ltd.

¿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
    RC-2013-RN-00946-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-09-10
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00946-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Maquet cardiopulmonary has determined that 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.
  • Acción
    Maquet is advising the customers to only use the Cardiohelp-I on AC power when possible. In the event of a battery defect alarm the AC power should be connected immediately. An upgrade to the sensor panel will be carried out to correct the issue.

Device

CARDIOHELP-I (Heart-lung bypass system)Serial numbers affected: 90140472, 901404544, 90410553ARTG...

Manufacturer

Maquet Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA