Events

Rappel de Philips IntelliVue Information Center iX (PIIC iX) software release A.01.XX (Central patient monitoring station)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00259-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-03-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00259-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.).
  • Action
    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...
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA