Events

Rappel de CARESCAPE Monitor B850, B650 or B450 Monitors with V2 software versions (Multiparameter patient monitors)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia 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-00659-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-24
  • 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-00659-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue due to partial loss of monitoring with the carescape monitor b850, b650 or b450. when connecting the pdm (patient data module) to the carescape b850, b650 or b450 monitor with software version 2, the pdm may not start communicating to the monitor and loss of the pdm parameters could occur. this issue happens after the following sequence of events:1. the pdm is connected to a transport pro or solar monitor.2. at least one arrhythmia or st-change snapshot is saved in the pdm.3. the pdm is then connected to the carescape bx50 monitor.4. more than 740 arrhythmia or st-change snapshots are then saved in the pdm.5. the pdm is then disconnected and connected back to the carescape bx50 monitor.
  • Action
    Customers are advised to follow these instructions provided in the customer letter to configure the CARESCAPE Bx50 monitor to store snapshots locally only and to prevent the PDM from starting to store the snapshots. A PDM that has exceeded the snapshot quantity and becomes unresponsive to CARESCAPE Bx50 monitors can be reset by connecting it to a Solar or Transport Pro monitor and doing a discharge. This process may need to be performed multiple times to clear all of the snapshot data. GE Healthcare will implement a software solution a permanent fix. This action has been closed-out on 02/02/2016.

Device

CARESCAPE Monitor B850, B650 or B450 Monitors with V2 software versions (Multiparameter patient m...
  • Modèle / numéro de série
    CARESCAPE Monitor B850, B650 or B450 Monitors with V2 software versions (Multiparameter patient monitors)ARTG Number: 115304
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd