Events

Rappel de Philips IntelliVue MX40 Patient Wearable Monitor s/w versions B.05.28, B.05.29 and B.05.32

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-2016-RN-01297-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-07
  • 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-2016-RN-01297-1
  • 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
    When the local "alarms on" configuration setting on the phillips intellivue mx40 patient wearable monitor is modified from its factory default, in certain software revisions, it will disable generation and delivery of ecg alarms to the philips intellivue information center ix (piic ix) without a visual indication on the piic ix that the ecg alarms have been disabled. if the generation and delivery of ecg alarms to the information center is disabled without a corresponding visual indication at the information center, a delay in treatment could occur.
  • Action
    Phillips is implementing software upgrade for affected Phillips IntelliVue MX40 Patient Wearable Monitors. Users with affected devices will be contacted by a Phillips Healthcare representative for the installation of the software upgrade. In the interim, users are advised to make sure that the MX40 Patient Wearable Monitor local configuration setting ‘Alarms On’ is configured to its factory default. Philips is providing instructions to change the local configuration settings in the customer letter.

Device

Philips IntelliVue MX40 Patient Wearable Monitor s/w versions B.05.28, B.05.29 and B.05.32
  • Modèle / numéro de série
    Philips IntelliVue MX40 Patient Wearable Monitor s/w versions B.05.28, B.05.29 and B.05.32Product Numbers: 865351, 865352 Exchange Part Numbers: 453564262531, 453564262551, 453564262571, 453564262591, 453564615351, 453564615371Product number and Exchange part number (identified as Service #) are displayed on the devices product label located on the back of the deviceARTG Number: 99204
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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