Events

Rappel de Philips IntelliVue Patient Monitors and Philips Avalon Fetal MonitorsIntelliVue Patient Monitors, software versions J.21.03 & J.21.19

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-2014-RN-01163-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-10-29
  • 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-2014-RN-01163-1
  • 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
    In time-synchronized automatic/sequence mode the noninvasive blood pressure (nbp) automatic measurement series is stopped inadvertently, if the repetition interval is increased manually by the user (e.G. from 5 to 15 minutes) in between two consecutive measurements.- a prompt message “any ongoing nbp measurement and automatic cycle stopped” is displayed and a single tone sounds when the measurement series is stopped.- after the automated measurement series has been stopped, nbp numeric, repetition time, and time to next measurement are no longer displayed, i.E. the nbp numeric field is blank.If the nbp measurement is stopped, and a patient’s blood pressure is not being monitored, a delay in treatment could occur.
  • Action
    A Philips Healthcare representative will contact customers with affected devices to arrange a software upgrade to correct the issues. During the interim period until the SW is upgraded, customers are advised to make sure, if the NBP repetition interval needs to be increased (e.g. from 5 to 15 minutes), to restart the automatic NBP measurement. This action has been closed-out on 12/08/2016.

Device

Philips IntelliVue Patient Monitors and Philips Avalon Fetal MonitorsIntelliVue Patient Monitors,...
  • Modèle / numéro de série
    Philips IntelliVue Patient Monitors and Philips Avalon Fetal MonitorsIntelliVue Patient Monitors, software versions J.21.03 & J.21.19Models and Product Numbers: MP5 (M8105A), MP5SC (M8105AS), MP5T (M8105AT), MP5 Upgrade (M8105AU), MP5SC Upgrade (866327)ARTG Number: 94238Avalon Fetal Monitors, software version J.30.58Models and Product Numbers: FM20 (M2702A), FM30 (M2703A), FM50 (M2705A)ARTG Number: 99202
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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