Events

Alerte De Sécurité sur Avance CS2

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
    2013-04-05
  • Date de publication de l'événement
    2013-04-05
  • 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_20130405.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 avance cs2 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning avance cs2, manufactured by ge healthcare. the avance cs2 may experience an intermittent display unit failure while in use, which could result in unexpected system performance and may include the loss of mechanical ventilation and balance gas delivery (medical air or n2o). according to the manufacturer, users may continue to use avance cs2, however in the event the display goes blank, users should stop use of the device and contact local ge healthcare representative. if the display goes blank, an audible alarm will notify the user of the loss of mechanical ventilation. below are the avance cs2 safety precautions in place if this should occur: alt o2 automatically activates, continuing to flow o2 and agent concentration (prevailing setting) at the previous setting to the patient breathing circuit. manual ventilation is available. furthermore, ge healthcare will correct all affected systems. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con252005 if you are in possession of the product, please contact your supplier for necessary actions. posted on 5 april 2013.

Device

Avance CS2
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare Avance CS2
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare