Events

Rappel de Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV & E-CAiOVX (used with CARESCAPE Monitors B850 and B650, Avance and Aisys Anesthesia Carestations, Engstrom Respiratory Carestation, or S/5 Anesthesia and Critical Care Monitors)

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-2014-RN-00488-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-29
  • 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-00488-1
  • 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 due to gas sampling pump failure associated with the compact airway gas modules. loosening of the gas sampling pump hex screw in the module pump may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. if this issue occurs, the monitor will show an alarm note on monitor screen of either "low gas sample flow" or "check sample gas out".
  • Action
    GE Healthcare will implement a correction for the affected modules. If the monitor is showing an alarm of “Low gas sample flow” or “Check sample gas out”, users are advised to check the following before continued use: 1. Check the water trap is not full or occluded. If full or occluded, empty/change the water trap. 2. Check gas sampling adapter at patient airway is not occluded. 3. Check sample line is not occluded. If occluded, change new gas sampling line. 4. Check gas exhaust outlet is not occluded. Ensure there is no blockage preventing the sample gas out flow to scavenging. If the above actions do not remove the alarm message(s), it may be due to the issue described above. Users are advised to remove the equipment from use and contact technical support or local service representative. This action has been closed-out on 02/02/2016.

Device

Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV & E-CAiOVX (used with CARESCAPE Monit...
  • Modèle / numéro de série
    Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV & E-CAiOVX (used with CARESCAPE Monitors B850 and B650, Avance and Aisys Anesthesia Carestations, Engstrom Respiratory Carestation, or S/5 Anesthesia and Critical Care Monitors)Affected serial number range # 6704120 - 6778756ARTG Number: 166230
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd