Events

Rappel de HAMILTON G5 / S1 ICU ventilators Software versions 2.00X up to 2.31X

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-2014-RN-00556-1
  • Classe de risque de l'événement
    Class I
  • 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-00556-1
  • 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 maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult). this vulnerability of the hamilton-g5 and hamilton-s1 exists within an interference-prone time window of 50 milliseconds after the ventilator detects a disconnection during a suctioning maneuver that has been initiated by the operator pressing the o2-enrichment key on the ventilator.
  • Action
    AHC Solutions is advising operators to always verify that ventilation continues after a suctioning manoeuvre. If ventilation does not continue it can be re-established by pressing the "Manual Breath" key, change the ventilation mode and switch to the "Stand-by Mode" and return to the previously used ventilation mode. AHC Solutionsis advising customer to permanently disable the automated suctioning manoeuvre on all affected ventilators using the software key provided with the customer letter to avoid the issue from occurring. This action has been closed-out on 29/01/2016.

Device

HAMILTON G5 / S1 ICU ventilators Software versions 2.00X up to 2.31X
  • Modèle / numéro de série
    HAMILTON G5 / S1 ICU ventilatorsSoftware versions 2.00X up to 2.31X
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd