Events

Rappel de IntelliVie Information Centre (PIIC) iX (centralised patient monitor)

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-01226-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-12-16
  • 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-01226-1
  • 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
    Calculated ecg leads, also referred to as reconstructed leads when viewed or printed at the information center ix, may misrepresent the ecg waveform morphology in some reconstructed leads. (the full set of six limb leads is commonly calculated from 2 limb leads.)following are the lead combinations that are affected.· lead i and lead iii-(avl incorrectly reconstructed)· lead i and lead avr-(avl lead incorrectly reconstructed)· lead iii and lead avf-(ii incorrectly reconstructed)with this combination and hexad on, the 4 derived v leads morphology will also be misrepresented in review applications.Trx/mx40 only – iii, v or avr, v (avl incorrectly reconstructed) review applications only.
  • Action
    Philips will be providing a software upgrade as a permanent correction. In the interm, users are informed that: - Arrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG. - The ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX. Users are also advised that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.

Device

IntelliVie Information Centre (PIIC) iX (centralised patient monitor)
  • Modèle / numéro de série
    IntelliVie Information Centre (PIIC) iX (centralised patient monitor)Affected Systems:866023 IntelliVue Information Centre iX, A.0866389 IntelliVue Information Centre iX, B.0866117 PIIC Classic UpgradeARTG 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