Events

Rappel de Mindray's V-Series Patient Monitors, software versions 2.4.0.18, 2.4.0.50, 2.4.0.60 and 2.4.1.18

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-01173-1
  • Classe de risque de l'événement
    Class I
  • 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-01173-1
  • 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 that involves the v-series drug calculator function specific to weight based calculations. this issue may occur when the patient’s weight is entered using either the v-series patient information dialog or the panorama central station (if it's in use with the central station). if the weight is manually entered, the issue will not occur. depending on the version of software in use, the most recent weight entered into the v-series patient setup dialog or the panorama central station may not be received by the calculator feature; the calculator may retain the original weight entered. additionally, the weight that is displayed in the drug calculator dialog may not reflect what was used for the calculation.If an incorrect dosing calculation results and medication is administered, immediate and/or long term health consequences may result depending on drug, dose, and duration.There are no reports of injuries associated with these issues.
  • Action
    Mindray is recommending that customers discontinue use of the Drug Calculator function until the software correction is performed. This action has been closed-out on 26/08/2016.

Device

Mindray's V-Series Patient Monitors, software versions 2.4.0.18, 2.4.0.50, 2.4.0.60 and 2.4.1.18
  • Modèle / numéro de série
    Mindray's V-Series Patient Monitors, software versions 2.4.0.18, 2.4.0.50, 2.4.0.60 and 2.4.1.18 Model Numbers: 1412 & 1414Serial Numbers: EGL19008969, EGL1B009996, EGL1B010000, EGL1B010014, EGL1B010016, EGL1B010341, EGL1B010352, EGL1C010807ARTG Numbers: 223384
  • Manufacturer
    Ulco Engineering Pty Ltd

Manufacturer

Ulco Engineering Pty Ltd
  • Source
    DHTGA