Events

Alerte De Sécurité sur Aestiva/5 7900 SmartVent

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
    2012-06-28
  • Date de publication de l'événement
    2012-06-28
  • 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_20120628b.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 aestiva/5 7900 smartvent the united states food and drug administrations (fda) has issued a class i recall concerning aestiva/5 7900 smartvent (serial number amrp01031 amrp00966 amrp01030 amrp00968 amrp00967 amrp01033 amrp00970 amrp00969), manufactured by ge healthcare, llc. the manufacturer has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of the aestiva 7900 anesthesia device. there is a potential for two vaporizers delivering agent at the same time. this could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. this may cause prolonged or persistent hypotension requiring medical intervention. to date, no injury has been reported to ge healthcare associated with this issue. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to fda websites http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event- detail.Cfm?action=detail&id=61639&w=06272012 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 28 june 2012.

Device

Aestiva/5 7900 SmartVent
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare, Aestiva/5 7900 SmartVent
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare