Events

Rappel de Tec 6 and Tec 6 Plus Vaporizers (Used to vaporize anaethesic agent Desflurane)Manufactured between 12 August 2005 and 03 December 2012 (AETJ29001 to AESR49001)

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-2013-RN-00845-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-14
  • 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-2013-RN-00845-1
  • 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 of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the tec 6 and tec 6 plus vaporizers. the low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers, resulting in fresh gas leaking to the atmosphere and a reduction in fresh gas delivered to the breathing system. a fresh gas leak in the vaporizer does not affect delivery of the set anaesthetic agent concentration but could result in a reduction in the volume of fresh gas delivered to the breathing system. this can lead to a reduction of flow of oxygen delivered to the patient, resulting in hypoxic gas concentrations and/or a reduction in the volume of anaesthetic agent delivered to the breathing circuit which may cause light anesthesia. the fresh gas leak may release nitrous oxide (n2o) gas into the ambient air and may result in clinician exposure.
  • Action
    GE Healthcare is providing users with an addendum with directions to perform the low pressure test with the dial turned to 12%. Users are advised by GE to discontinue use of vaporizors if it fails at 12%. If the vaporizer passes, the device can continue to be used. GE will be repairing/replacing the seals on all Tec 6 and Tec 6 Plus vaporizers as a permanent fix in August 2013.

Device

Tec 6 and Tec 6 Plus Vaporizers (Used to vaporize anaethesic agent Desflurane)Manufactured betwee...
  • Modèle / numéro de série
    Tec 6 and Tec 6 Plus Vaporizers (Used to vaporize anaethesic agent Desflurane)Manufactured between 12 August 2005 and 03 December 2012 (AETJ29001 to AESR49001)ARTG Number: 140207
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd