Events

Retiro De Equipo (Recall) de Philips IntelliVue Information Centre and Philips IntelliVue Information Centre iX (Central patient monitor unit)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2012-RN-01261-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-12-13
  • 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-2012-RN-01261-1
  • 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
    An internal audio cable connector may have diminished retention force due to damaged contacts. this diminished retention force may lead to intermittent or loss of audible alarms.
  • Acción
    As an interim measure, Philips is advising users not to rely on the audible alarm from the central unit and to report any issues identified. A permanent fix is being implemented to replace the contacts that might cause the problem.

Device

Philips IntelliVue Information Centre and Philips IntelliVue Information Centre iX (Central patie...
  • Modelo / Serial
    Philips IntelliVue Information Centre and Philips IntelliVue Information Centre iX (Central patient monitor unit)ARTG number: 94237
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA