Events

Notificaciones De Seguridad De Campo acerca de ultrasound system ARIETTA Prologue

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 Hitachi, Ltd..

¿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
    2017-06-07
  • 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
    Operation of arietta prologue becomes unstable due to contact failure between backend unit (be, screen side) and frontend unit (fe, probe connection side). this may cause the following malfunctions: - the monitor of be is once disappeared and return to the home screen display. - the connection of probe isn’t recognized. - it doesn’t charge the battery of be in spite of setting the battery cutoff switch to enable mode. - it doesn’t charge the battery of be in spite of setting the battery cutoff switch to enable mode. - although fe and be are connected as wired communication, it is recognized as wireless and an alarm would occur. - it would stop the scanning during the examination and returns to the home screen display. - it would freeze the ultrasound image during the scanning (screen update would stop). ' - the communication between fe and be would be lost and fe will finally shut it down. - a hardware error message would be displayed when the machine boots up.

Device

ultrasound system ARIETTA Prologue

Manufacturer

Hitachi, Ltd.
  • Empresa matriz del fabricante (2017)
    Hitachi Ltd
  • Source
    AMPMDRS