Events

Rappel de Panorama Central Station, software versions 10.0 to 11.3 and patient Monitoring Network

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Ulco Engineering Pty 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-01158-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-10-30
  • 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-01158-1
  • 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
    Mindray has identified an issue related to the panorama central station where full disclosure data (includes patient data, waveforms, and events) may lag behind the panorama system time clock when the panorama central station is in use with mindray’s v-series monitor. the full disclosure data may be a minimum of 6 seconds behind the panorama system time clock and may grow at a rate of 5 to 7 seconds per day if the v-series monitor remains connected to the panorama central station without interruption. this issue may also lead to the inability to print the most recent “full disclosure” data if the lag time exceeds 21 seconds. if the lag time exceeds 30 seconds, non-invasive blood pressure measurement contained in the “list trends” may appear out of time order. there are no reports of injuries associated with these issues.
  • Action
    Mindray is arranging software upgrade to eliminate this issue. Customers are advised that a break in communications, admitting or discharging a patient or putting the V-Series in standby will, temporarily, eliminate the issue. This action has been closed-out on 26/08/2016.

Device

Panorama Central Station, software versions 10.0 to 11.3 and patient Monitoring Network
  • Modèle / numéro de série
    Panorama Central Station, software versions 10.0 to 11.3 and patient Monitoring NetworkSerial Number: RM01940-F2ARTG Numbers: 223386
  • Manufacturer
    Ulco Engineering Pty Ltd

Manufacturer

Ulco Engineering Pty Ltd
  • Source
    DHTGA