Events

Rappel de Carestation 620, 650 and 650c A1 Anaesthesia devices Carestation

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-00640-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-05-18
  • 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-00640-1
  • 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 have identified 2 issues with carestation 620, 650 and 650c systems which have the potential for elevated fico2 and unexpected system malfunction.1. an incomplete seal can exist between the disposable absorber and the breathing circuit lower assembly of the carestation 600 series systems. this incomplete seal can allow rebreathing of patient gases that have bypassed the carbon dioxide (co2) absorbent material and could result in unintended elevated inspired levels of co2 (fico2), which could lead to hypercarbia.2. an unexpected transition to a system malfunction state can occur, which will display the following message on the screen: “system malfunction internal problem prevents normal operation. use backup ventilation. to restart, turn power off and on". if the system malfunction is left unresolved, it could result in loss of mechanical patient ventilation, which could lead to hypoxia. to date, there have been no injuries reported to ge as a result of these issues.
  • Action
    GE will arrange for correction of devices. In the interim, the following instructions are provided: 1. If elevated FiCO2 is observed, increasing the flow of fresh gas can reduce the volume of patient gas that could be rebreathed, consistent with standard clinical practices. If the FiCO2 cannot be adequately reduced with this action, consider switching to another anaesthesia device. Use a CO2 monitor whenever anaesthesia is delivered. 2. If unexpected transition to a System Malfunction state occurs: - Manually ventilate patient (move bag-to-vent switch to bag position, adjust APL, increase Oxygen (O2) flow as needed to fill the manual bag), - Monitor patient, - Cycle system power off then on by pressing the power switch twice 5 seconds apart to run the power up self-tests and restore normal operation. Ensure existing pre-use instructions are followed and verify that a method of back-up ventilation, independent of the anaesthesia machine, is available and functional prior to use.

Device

Carestation 620, 650 and 650c A1 Anaesthesia devices Carestation
  • Modèle / numéro de série
    Carestation 620, 650 and 650c A1 Anaesthesia devices Carestation 620 A1 GTIN: 00840682103985Carestation 650 A1 GTIN: 00840682103947Carestation 650c A1GTIN: 00840682103954ARTG Number: 93955
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd