Events

Rappel de Hexad 12-Lead ECG Monitoring derivation with Philips IntelliVue Patient Monitors, software versions K.21.54 or L.00.96

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-00090-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-01-20
  • 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-00090-1
  • 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
    The st elevation alarm on the patient monitor or standalone x2 measurement module will not sound when indicated for all chest leads derived using hexad 12-lead ecg monitoring in the following host monitor configuration:st analysis: “off” ste: “on“ste alarms: “on”the problem only occurs if either of the affected philips intellivue measurement modules are used with philips intellivue patient monitors with hexad option #c54 (also bundled in options h11, h41, h42, cp2), or if an affected x2 measurement module is used in standalone mode (i.E., not connected to another monitor).There is potential for delay in diagnosis due to the monitor not alarming for st elevation on the chest leads.
  • Action
    Philips Healthcare is advising users to ensure the ST Analysis is switched to ON when using STE measurement. A software upgrade will be installed as a permanent correction.

Device

Hexad 12-Lead ECG Monitoring derivation with Philips IntelliVue Patient Monitors, software versio...
  • Modèle / numéro de série
    Hexad 12-Lead ECG Monitoring derivation with Philips IntelliVue Patient Monitors, software versions K.21.54 or L.00.96Affected Philips IntelliVue Measurement Modules:Model Number: X1Product Number: M3001A Software Revision: K.21.54 or L.00.96Model Number: X2Product Number: M3002A Software Revision: K.21.54 or L.00.96 ARTG Number: 94238
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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