Events

Notificaciones De Seguridad De Campo acerca de Symbia E and e.cam systems

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 Siemens.

¿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
  • 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 have received complaints regarding incidents where collimator change activities have resulted in operator injury. our investigation found that these incidents may have been avoided by operators properly following specified instructions. the system was designed to safely store and exchange col mators, however ifthe instructions are not followed serious injuriesi such as broken bones and lacerations, may occur. we have determined that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasize the proper co imator change process.

Device

Symbia E and e.cam systems
  • Modelo / Serial
  • Manufacturer
    Siemens

Manufacturer

Siemens
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    AMPMDRS