Events

Retiro De Equipo (Recall) de CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system)

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-00281-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-03-28
  • 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-00281-1
  • 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
    1 - there have been reported cases of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touchscreen) of the cardiohelp device. all manual settings are lost and the system will revert back to the original clinical settings.2 - through internal testing, it has been determined that there is a possibility that electromagnetic interference due to electric current fluctuations may cause pressure valves on the display to "freeze".
  • Acción
    Maquet is providing work around instructions to prevent risk of injury to the patient in the unlikely event of the failure mode occurring during use. Maquet has updated its current CARDIOHELP-i software to version 3.3.2.0 and this will be installed by an authorised Maquet service technician.

Device

CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system)
  • Modelo / Serial
    CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system)Serial Number: All devices up to 90410628 excluding S/N 90410622 and 90410626ARTG Number: 179014
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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