Events

Notificaciones De Seguridad De Campo acerca de Dialog+ Dialysis Machines with Software 8.2A in combination with Option Adimea

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por B. Braun.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-10-10
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    We became aware of a software error in software (sw) 8.2a of the dialog+ dialysis machine affecting the timer/stop watch function. this timer function only serves as a support to the user to remind him of an action that has to be taken by him. the failure occurs only in sw 8.2a and only in combination with option adimea. in certain conditions and on rare occasions the warning triggered to remind the user is reset by the machine without user interaction. the user might not be aware that the reminder was triggered at all. .

Device

Dialog+ Dialysis Machines with Software 8.2A in combination with Option Adimea

Manufacturer

B. Braun