Events

Rappel de Hamilton Medical G5 / S1 Ventilator with software version V2.42

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia.

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-00285-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-15
  • 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-00285-1
  • 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
    Investigations have shown that after performing the suctioning manoeuvre, including disconnecting the patient, suctioning and reconnecting the patient, the present pattern of ventilation may not continue as expected due to a software issue. under certain conditions, a different ventilation mode than the operator selected mode may be applied. this situation can occur independent from the selected patient group (neonate, paediatric or adult). if the ventilator’s incorrect behaviour is not detected, the patient is ventilated with the ventilation mode active prior to the pre-oxygenation phase. in the worst case, the patient may be either hypo ventilated or hyperventilated.
  • Action
    The sponsor Taleb is advising customers that a software update (v 2.60) will be installed on all affected units by June/July 2016. As an interim measure, the sponsor will permanently disable the automated suctioning manoeuvre functionality on all affected units. In addition, the operator must verify that the ventilation continues after a suctioning manoeuvre is finished. If the ventilation does not continue as expected, one of the following options can be used to re-establish ventilation as set: • Press the “Manual Breath” key on the ventilator’s front panel. • Select a different ventilation mode. • Switch to the “Standby mode” and return to the previously used ventilation mode. This action has been closed-out on 09/05/2017.

Device

Hamilton Medical G5 / S1 Ventilator with software version V2.42

Manufacturer

The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia