Events

Retiro De Equipo (Recall) de Philips IntelliVue Information Center iX (PIIC iX) software release A.01.XX (Central patient monitoring station)

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-2013-RN-00259-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-03-21
  • 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-00259-1
  • 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
    Philips has received a customer report that the piic ix (release a.01.Xx) central stations that are connected to a database server (dbs) may not be able to complete a restart/reboot resulting in the loss of central monitoring. this defect occurs when the following two criteria are met:1. the workflow for reviewing stored patient data on the piic ix involves the modification of the default trend scales in the retrospective review applications and these trend scales are customised for hundreds of different patients (within a period of seven days or less); and2. a planned/unplanned event resulting in the restart/reboot of the piic ix central stations (e.G. deliberate reboot, network connection to the dbs is lost and piic central stations go into local mode, power failure, etc.).
  • Acción
    End users are provided with instructions to prevent the defect from occurring. A Philips Healthcare representative will contact customers with affected devices to arrange for the installation of updated PIIC iX software, resolving this issue on all affected units.

Device

Philips IntelliVue Information Center iX (PIIC iX) software release A.01.XX (Central patient moni...
  • Modelo / Serial
    Philips IntelliVue Information Center iX (PIIC iX) software release A.01.XX (Central patient monitoring station)ARTG Number: 94237
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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