Events

Alerte De Sécurité sur Carestation 620, Carestation 650, and Carestation 650c Anaesthesia Systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par GE Healthcare.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2017-10-13
  • Date de publication de l'événement
    2017-10-13
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171013.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: ge healthcare carestation 620, carestation 650, and carestation 650c anaesthesia systems the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning carestation 620, carestation 650, and carestation 650c anaesthesia systems, manufactured by ge healthcare. the manufacturer 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. the manufacturer 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. the manufacturer is releasing revised parts that minimise the likelihood of incomplete gas flow through the co2 absorbent canister. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2017-rn-01300-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 october 2017.

Device

Carestation 620, Carestation 650, and Carestation 650c Anaesthesia Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare Carestation 620, Carestation 650, and Carestation 650c Anaesthesia Systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare