Events

Rappel de Rechargable Lithium Ion Battery used in Beneview T1 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 Mindray Medical 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-2017-RN-01065-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-16
  • 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-2017-RN-01065-1
  • 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 the potential for overheating of the rechargeable lithium ion battery used in beneview t1 patient monitors. the initial failure mode and clinical assessment indicated that the problem may result in the battery overheating, smoke, and the possible melting of the monitor shell under extreme circumstances. to date, there are no reports of patient injuries associated with this potential issue.
  • Action
    1. Pass this Notice to all within your organisation or to any organisation where the potentially affected device(s) have been transferred. 2. Stop using the Rechargeable Lithium Ion battery of Beneview T1 Patient Monitor. Mindray service representatives will contact users to replace the affected batteries. 3. Store the affected batteries properly as follows; · Do not charge batteries. · Prevent short circuiting of the batteries. For example, covering the two ends of the connector with insulating tape. · Store the batteries at cool places(=21°C) away from combustibles. · Store the batteries separately, do not mix, overlay or pile up them with other batteries. 4. Mindray Service Representatives will visit to collect and dispose of the batteries.

Device

Rechargable Lithium Ion Battery used in Beneview T1 Patient Monitors
  • Modèle / numéro de série
    Rechargable Lithium Ion Battery used in Beneview T1 Patient MonitorsMultiple Battery Serial NumbersARTG Number:223384
  • Manufacturer
    Mindray Medical Australia Pty Ltd

Manufacturer

Mindray Medical Australia Pty Ltd