Events

Alerta De Seguridad para Aestiva/5 7900 SmartVent

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por GE Healthcare.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-06-28
  • Fecha de publicación del evento
    2012-06-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120628b.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    Medical Device Safety Alert: GE Healthcare, Aestiva/5 7900 SmartVent
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare