Events

Rappel de Aisys CS2 and upgraded Aisys anaesthesia devices (with software version 10.X)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia 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-00339-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-03-23
  • 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-00339-1
  • 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
    Aisys cs2 anaesthesia devices and upgraded aisys anaesthesia devices deliver a momentary, self-correcting increase of the anaesthetic agent, affecting the inhaled and exhaled concentrations for a short time, upon either of the following setting changes:· a fresh gas setting change from 95%-25% oxygen to only air (21% oxygen).· any total flow setting change while using 21% oxygen (air only). the momentary bolus of anaesthetic agent will not occur with nitrous oxide as the carrier (balance) gas or if the oxygen concentration is set above 21% (air only). delivery of this momentary bolus of anaesthetic agent is potentially hazardous because it could lead to hypotension in certain vulnerable paediatric patients when 21% oxygen (air only) is used.
  • Action
    GE Healthcare is advising if possible, an alternative device should be used for paediatric patients until this safety issue is resolved. If 21% O2 in fresh gas is used, any adjustment to the fresh gas flow will deliver a bolus of inhaled anaesthetic agent, however the effects are short in duration. If the issue occurs, the device will automatically recover and return to steady state. Depending on your system configuration, one or both of these alarms could trigger if this issue occurs: -Clinician adjustable “Fi XXX High” alarm (XXX denotes the specific agent) -Alarm if respiratory gas monitoring is not present. GE will be providing a correction as a permanent fix. This action has been closed-out on 20/02/2017.

Device

Aisys CS2 and upgraded Aisys anaesthesia devices (with software version 10.X)

Manufacturer

GE Healthcare Australia Pty Ltd