Events

Retiro De Equipo (Recall) de Philips Expression Information Portal (IP5) (secondary display control unit for the Expression MRI Patient Monitoring 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 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-01325-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-16
  • 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-01325-1
  • 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
    Upon power up, the ip5 may fail to produce audio. "audio" includes touch screen tones, qrs/spo2 modulation tones and audible alarms. all other functionality of the ip5 is unaffected (ie. waveforms, numeric values, visual alarm indications). this problem will only occur upon power up of the device. accordingly, the scenario where audio is present at the onset of monitoring and then is lost during monitoring will not occur.
  • Acción
    Philips Healthcare is providing users work around instructions to follow as an interim measure. A software update will be installed to correct the problem.

Device

Philips Expression Information Portal (IP5) (secondary display control unit for the Expression MR...
  • Modelo / Serial
    Philips Expression Information Portal (IP5) (secondary display control unit for the Expression MRI Patient Monitoring System)Serial Numbers: US23200375, US23200376, US23200377 ARTG Number: 189095
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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