Events

Rappel de Philips IntelliVue MX40 Wearable Patient Monitors manufactured prior to the 6th of July 2015

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-2017-RN-00732-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-06-06
  • 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-2017-RN-00732-1
  • 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 identified a higher than expected incidence of speaker failures, which results in the loss of audible alarms when the device is in monitor mode. the failure of the speaker results in the audio capabilities of the speaker being degraded and/or no sound at all. operation in telemetry mode is unaffected by speaker failure until disconnected from the information center, either intentionally or unexpectedly.Monitor mode: the mx40 provides local patient monitoring for a period limited by its battery life. the device will annunciate audible & visual alarms using the speaker & display on the mx40 when the alarm conditions are triggered. extended use in this mode raises the risk of the speaker failing.Telemetry mode: all alarming is automatically managed at the information center. mx40 speaker volume is set to zero & the display is off unless the user enables monitor mode. the device will automatically switch to monitor mode if it loses connection to the telemetry network.
  • Action
    A Philips Healthcare representative will contact customers with affected devices to arrange for shipment of a replacement unit. The replacement device is currently manufactured with the improved hardware speaker design and latest software (includes speaker detection capability and INOP messaging) release. An interim workaround is also given in the Customer Letter until such time as the replacement can be made.

Device

Philips IntelliVue MX40 Wearable Patient Monitors manufactured prior to the 6th of July 2015
  • Modèle / numéro de série
    Philips IntelliVue MX40 Wearable Patient Monitors manufactured prior to the 6th of July 2015Product Number: 865351 Service Number: 453564262531 and 453564262551Product Number: 865352Service Number: 453564262571 and 453564262591Serial Numbers: lower than US03556362ARTG Number: 99204
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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