Events

Rappel de All Carestation 620, 650 and 650c Anaesthesia systems

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-2017-RN-01300-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-10-11
  • 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-2017-RN-01300-1
  • 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
    Ge healthcare has recently become aware that an incomplete seal can exist between the co2 absorber and the breathing circuit co2 bypass port assembly of the carestation 600 series systems. an incomplete seal can allow rebreathing of patient gases that have bypassed the co2 absorbent material and could result in unintended elevated levels of inspired co2 (fico2), which could lead to hypercarbia. to date, there have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising users as an interim solution to increase the flow of fresh gas to reduce the volume of patient gas that is rebreathes if elevated FiCO2 levels are observed. If the FiCO2 levels cannot be adequately reduced with this action, users should consider switching to another anaesthesia delivery device. GE is releasing revised parts that minimise the likelihood of incomplete gas flow through the CO2 absorbent canister. GE will be in contact with affected customers to arrange for correction. Going forward, the updated parts will be included in the 12-month preventative maintenance replacement schedule for the Carestation 600 Series system.

Device

All Carestation 620, 650 and 650c Anaesthesia systems

Manufacturer

GE Healthcare Australia Pty Ltd