Alerta De Seguridad para Delta, Delta XL, Vista XL, Gamma XXL and Kappa

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

¿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
    2011-10-24
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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
    Field safety notice: drager delta, delta xl, vista xl, gamma xxl and kappa medical device supplier, draeger medical hong kong ltd, issued an important safety notice concerning software anomaly of delta, delta xl, vista xl, gamma xxl and kappa with software version vf6.2, vf6.3, vf6.4, vf7.1 and vf7.2. it is reported that the ventricular fibrillation (vfib) arrhythmias will not be recognized by the monitor and will not alarm when the masimo set pod is used for spo2 measurements. there have been no patient injuries reported. according to the local supplier, hong kong is not affected since the software versions in all installation devices with masimo spo2 pod are vf7.3 or higher. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Drager Delta, Delta XL, Vista XL, Gamma XXL and Kappa
  • Manufacturer

Manufacturer