Events

Rappel de Hamilton Galileo Ventilator when used with Flexport Communication Interface Protocol version 1.2

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-2014-RN-00582-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-29
  • 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-2014-RN-00582-1
  • 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
    The monitored minute volumes (vmin) are reported at ten times actual value on the bedside monitor. the source of this error is associated with a change in the flexport communication protocol between versions 1.1 and 1.2. all alarms and setting levels on the bedside monitor continue to perform properly and are unaffected by this error. the reported x10 volumes would be an obvious error to the clinician.
  • Action
    Medtel Australia is notifying their customers of the issue and advising that the ventilator performance is not affected. A software update will be implemented to correct the issue. This action has been closed-out on 12/02/2016.

Device

Hamilton Galileo Ventilator when used with Flexport Communication Interface Protocol version 1.2
  • Modèle / numéro de série
    Hamilton Galileo Ventilator when used with Flexport Communication Interface Protocol version 1.2Model Number: 90436A-07ARTG Number: 135706
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA