Events

Retiro De Equipo (Recall) de Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Distributed from 6 March 2012 to 31 December 2015

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-2016-RN-00460-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-04-22
  • 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-2016-RN-00460-1
  • 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
    Issues have been identified regarding the video display cables, video display assembly (internal pc board) and the pneumatic assembly for certain cardiosave hybrid and rescue iabps.1 - the cardiosave iabp may have intermittent connectivity issues with the video display cables causing display blanking followed by a “system failure” audible alarm and shut down.2 - the cardiosave iabp video display assembly may shutdown during operation due to a short on the video generator board.3 - intermittent connection with the cardiosave pneumatic module connector resulting in iabp startup failure and/or iabp shutdown.To date, there has been no reported patient harm or adverse events attributable to these issues.
  • Acción
    Maquet is advising users to ensure an alternative device is available at all times as a backup, and that the affected units should not be used during ground or air transport. Maquet will be performing an on-site service to correct the reported issues. This action has been closed-out on 23/01/2017.

Device

Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Distributed from 6 Marc...
  • Modelo / Serial
    Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)Distributed from 6 March 2012 to 31 December 2015ARTG Number: 118266
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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