Events

Rappel de Hamilton Medical G5 / S1 Ventilator, software versions between V2.00 and V2.31

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-2014-RN-00557-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-05-28
  • 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-00557-1
  • 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 ventilation and alarms of a hamilton g5 or hamilton s1 ventilator can be suppressed unintentionally after the activation of a suctioning manoeuvre by the operator. this situation can occur regardless of the selected patient group (neonatal, paediatric, & adult). this vulnerability of the hamilton –g5 and hamilton –s1 exists under specific conditions within an interface prone time window of 50 milliseconds after the ventilator detects a disconnection during a suctioning manoeuvre that has been initiated by operator pressing the o2-enrichment key on the ventilator. this issue could result in the termination of mechanical ventilation and suppression of alarms with the exception of the medium-priority alarm “loss of peep” when peep is set > 4 mbar. please note that the ambient and exhalation valves of the ventilator are opened so that a spontaneously breathing patient can breathe room air unassisted by the ventilator.
  • Action
    Permanently disable the automated suctioning manoeuvre functionality on all Hamilton G5/ Hamilton S1 ventilators by using a software key provided by the manufacturer. This correction will be undertaken during the preventative maintenance due in June/July 2014. Thia action has been closed-out on 28/01/2016

Device

Hamilton Medical G5 / S1 Ventilator, software versions between V2.00 and V2.31

Manufacturer

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