Events

Rappel de Xhibit Central Station (patient monitoring system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Ecomed 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-2016-RN-00572-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-05-03
  • 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-00572-1
  • 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 manufacturer, spacelabs, has received one report of values for patient height and weight being switched when input at the xhibit central station, causing a bedside monitor body surface area (bsa) calculation to be in error. no one has been injured due to this error. in order for the error to occur, the height and weight values must have been entered at the xhibit central station, the cardiac output cable must be attached for use, and the cardiac output function on the bedside monitor must be initiated. the bsa value is determined by the monitor from height and weight of the patient and is used in subsequent hemodynamic calculations such as cardiac index. the bedside monitor also contains a “drug calculator” for computation of drug dose conversions by weight or other units of measure. in situations where the failure mode has occurred, this initial value will not be accurate due to the height and weight transposition.
  • Action
    Ecomed is providing users with work around instructions to follow as an interim measure. Affected customers will be provided with a software upgrade as a permanent correction. This action has been closed-out on 27/01/2017.

Device

Xhibit Central Station (patient monitoring system)
  • Modèle / numéro de série
    Xhibit Central Station (patient monitoring system)Model Number: 96102Serial Numbers: SLA1114F00831, SLA0114F00450ARTG Number: 237776
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Ecomed Pty Ltd

Manufacturer

Ecomed Pty Ltd