Events

Notificaciones De Seguridad De Campo acerca de TruVidia™

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
  • 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
    During testing, trumpf medical found that the radiated emissions from the truvidia ™ wireless receiver exceeded the regulatory limits. it is unlikely, but it is possible that the radiated emissions will affect other devices in the operating room, which could cause other devices to malfunction. the frequency of interference and associated risks will depend on the immunity of other devices to the emitted emissions and the nature of the equipment error in the operating room used at that time. trumpf medical has not received any complaints or allegations of injuries related to the issue.

Device

TruVidia™

Manufacturer

TRUMPF Medizin Systeme GmbH + Co. KG