Events

Rappel de Hamilton-G5 and Hamilton -S1 Ventilators with software versions v2.41, v2.42 and v2.50

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par AHC Solutions 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-2016-RN-00450-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-29
  • 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-2016-RN-00450-1
  • 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 analysis of a customer complaint has identified an issue related to suctioning with the use of the hamilton-g5 and hamil ton-s1 ventilators. after performing the suctioning manoeuvre, including disconnecting the patient, suctioning, and then reconnecting the patient, the preset pattern of ventilation may not continue as expected. under certain conditions, a different ventilation mode than the operator selected mode maybe applied; this situation can occur independent from the selected patient group (neonate, paediatric, or adult). this situation may occur if the ventilation mode changes during the pre-oxygenation phase. after the suctioning manoeuvre is finished and the patient is reconnected, the ventilation mode active before the pre-oxygenation phase is used. under these conditions, the ventilation mode displayed by the ventilator is not the same as the applied ventilation mode. in the worst case, the patient may be either hypo ventilated or hyperventilated.
  • Action
    AHC is providing instructions to deactivate the suctioning option on all affected ventilators until a software upgrade to version 2.60 has been installed. Users are advised to ensure there are alternative suction devices available.

Device

Hamilton-G5 and Hamilton -S1 Ventilators with software versions v2.41, v2.42 and v2.50
  • Modèle / numéro de série
    Hamilton-G5 and Hamilton -S1 Ventilators with software versions v2.41, v2.42 and v2.50Product codes: 159001 & 159005Multiple Serial numbers affected ARTG number: 113999
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd