Events

Rappel de WATO EX-65 and A-Series (A5/A7) anaesthesia machines

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-01066-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-29
  • 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-01066-1
  • 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 a potential issue related to electrically erasable programmable read-only memory (eeprom) which will only occur if the system’s total number of write cycles to a particular range of memory locations has exceeded the life specification of the eeprom. the issue will only manifest at start up or at the end of a case; it will not occur during a case. there are no adverse effects on the patient.To date, there have been no reports of injuries associated with this issue.
  • Action
    The manufacturer recommeds cessation of the use of machines which have experienced this fault. Units which have not experienced the fault may be used as normal. A software upgrade is planned.

Device

WATO EX-65 and A-Series (A5/A7) anaesthesia machines
  • Modèle / numéro de série
    WATO EX-65 and A-Series (A5/A7) anaesthesia machinesMultiple Serial NumbersARTG Number: 158607
  • Manufacturer
    Mindray Medical Australia Pty Ltd

Manufacturer

Mindray Medical Australia Pty Ltd