Events

Retiro De Equipo (Recall) de Philips IntelliVue Information Center (PIIC) iXAll PIIC iX Surveillance stations including:866023 IntelliVue Info Center iX A.0866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0867141 IntelliVue Info Center iX B.0

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-2018-RN-00026-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-05
  • 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-2018-RN-00026-1
  • 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 been made aware of a potential problem with all piic ix surveillance and patient link revisions. the issue will occur after a surveillance station is first restarted during the year 2018. after that initial restart, the station will thereafter no longer perform patient discharge and transfer operations. any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the surveillance station during such restart.
  • Acción
    Philips is advising users that in order to avoid this issue, do not intentionally restart any surveillance stations that have been running normally since the new year. Users may use the workflows described in the attachment provided with the customer letter to avoid operations that may cause the surveillance station to restart. When a patient is discharged, confirm that the patient is discharged.

Device

Philips IntelliVue Information Center (PIIC) iXAll PIIC iX Surveillance stations including:866023...
  • Modelo / Serial
    Philips IntelliVue Information Center (PIIC) iXAll PIIC iX Surveillance stations including:866023 IntelliVue Info Center iX A.0866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0867141 IntelliVue Info Center iX B.0ARTG 94237
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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