Events

Rappel de MEDRAD Veris MR Vital Signs 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 Imaxeon 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-2013-RN-01312-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-11
  • 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-2013-RN-01312-1
  • 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
    Bayer healthcare has identified that the main board, p/n 301641, installed in some medrad veris mr monitors units may be faulty and could lead to unexpected shutdown of the system while in use. this would result in the loss of vital signs information from the monitor. failure of the monitor may not only result in an inability of the user to view vital signs information but this failure may also go unrecognised. this may present an increased risk to patients who required that their vital signs be monitored while undergoing an mri exam such as those who are sedated, anesthetised or who are on critical medications. thus, it is required to continually monitor the system to ensure proper functioning.
  • Action
    For those with affected units, Imaxeon Service Representative will be in contact to schedule an appointment to come and replace the main board. Imaxeon have established a prioritisation plan for the corrections which first addresses customers who have reported the problem and those who have the most critical medical diagnostic needs

Device

MEDRAD Veris MR Vital Signs Monitor
  • Modèle / numéro de série
    MEDRAD Veris MR Vital Signs Monitor Monitor serial numbers : 31710, 31031, 32507, 32551, 32884, 32897, 36417, 38312Monitors containing main board (P/N 3010641) lot numbers 21-39ARTG number: 118213
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

Imaxeon Pty Ltd
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    DHTGA