Events

Notificaciones De Seguridad De Campo acerca de JUPITER, ARTIS and TruSystem 7500

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 TRUMPF Medizin Systeme GmbH + Co. KG.

¿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
    2015-01-12
  • 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
    Trumpf medical has received reports that in some cases the above operating tables were moving automatically and without conscious use of the remote control. no injuries to patients or users. reported cases suddenly occurred during preparation or surgery. through individual investigations, each time it was determined that the problem was a button on the remote control that was mechanically damaged by external influences. the defective key corresponded to the reported direction of movement each time. key injuries may have occurred due to e.G. collision with other objects or compression between moving parts. as a result, the remote control can, at any time, permanently or temporarily transmit a movement command at a time when a particular shake or movement occurs. the operating table cannot differentiate the throw with such and the desired movement commands. based on investigations, trumpf medical has determined that remote controls were used controls that show clear damage and are therefore no longer permitted to use. automatic movement can be prevented by proper inspection before use.

Device

JUPITER, ARTIS and TruSystem 7500

Manufacturer

TRUMPF Medizin Systeme GmbH + Co. KG