Events

Rappel de Spacelabs Healthcare Qube Compact Monitor (Multi parameter transportable patient 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 Medtel 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-2012-RN-01136-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-08
  • 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-2012-RN-01136-1
  • 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
    There is a potential failure of the qube compact monitor where the input power can fail even though the power source at the wall has not been interrupted. the monitor automatically goes into battery mode and functions normally, including the low battery alerts, until the batteries become depleted and the monitor turns off. in addition, there is the potential for the qube compact monitor to fail to turn on.
  • Action
    As an interim measure, Medtel is providing work around instructions to reduce the probability of occurrence. New hardware will be installed to permanently correct the issue as soon as possible.

Device

Spacelabs Healthcare Qube Compact Monitor (Multi parameter transportable patient monitor)
  • Modèle / numéro de série
    Spacelabs Healthcare Qube Compact Monitor (Multi parameter transportable patient monitor)Serial Numbers:1390 - 000340, 1390 - 000339, 1390 - 000338 & 1390 - 000337ARTG Number: 108755
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA