Events

Rappel de Philips IntelliVue Information Center (PIIC) iX system (A Centralized Patient Monitoring System)

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-2015-RN-00077-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-01-30
  • 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-2015-RN-00077-1
  • 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 is informing that a software defect has been identified that involves the use of the “change bed label” feature at the information center ix. if the configuration for this item is set to “optional” and a user selects the “location” button within the “manage patient” menu and makes a change to the patient location, alarms for sp02 and/or non invasive blood pressure (nbp) will become disabled without visual notification (bell with an “x”) to the user. this problem only happens when the patient is monitored using a networked intellivue trx telemetry m4841/trx4851a patient worn device (pwd).
  • Action
    Philips is providing instructions to the users to prevent this issue from occurring: Customers/users should: 1) Disable the Change Bed Label field in Patient Management. This is accomplished by changing the feature from ‘Optional to ‘Hidden’ 2) All patient transfers must be performed using the Transfer key in the Manage Patient application. Philips is providing a software correction to customers with impacted devices at no charge. This action has been closed-out on 08/08/2016.

Device

Philips IntelliVue Information Center (PIIC) iX system (A Centralized Patient Monitoring System)
  • Modèle / numéro de série
    Philips IntelliVue Information Center (PIIC) iX system (A Centralized Patient Monitoring System)Part Numbers: 866023 (IntelliVue Info Center iX), 866024 (PIIC iX Upgrade), 866117 (PIIC Classic Upgrade)Serial Numbers: Release A.00, A.01 and A.02 versions in use with M4841A/TRx4851 telemetry devicesARTG Number: 94237
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA