Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Trumpf Medical Systems, Inc..

¿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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 049 04 16 000
  • Fecha de inicio del evento
    2016-04-12
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9177
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The universal arm support enables precise positioning of the patient’s arm during surgical procedures. during our continuous monitoring and analysis of trumpf medical products installed in the field customers have reported that the universal arm support may be unable to hold its set position and support the arm of the patient. the feedback describes the issue occurring while attempting to secure the position of the device. with this preventive field action trumpf medical proactively wants to ensure the safe intended use of the universal arm support. the product has not been involved with any reported injuries.

Device

Universal Arm Support
  • Modelo / Serial
    Product Name: Universal Arm Support 450 Model Number: 1697630 up to serial number: 102441510 Product Name: Universal Arm Support 450 T Model Number: 1697635 up to serial number: 102472407 Product Name: Universal Arm Support 600 Model Number: 1697639 up to serial number: 102406761 Product Name: Universal Arm Support 600 T Model Number: 1697651 up to serial number: 102412823 Product Name: Universal Arm Support 450 U Model Number: 1697660 up to serial number: 102426024 Product Name: Universal Arm Support 450 U T Model Number: 1697662 up to serial number: 102452250
  • Descripción del producto
    Arm Support
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Representante del fabricante
    Al-Faisaliah Medical System, Riyadh (01) 2119999
  • Source
    SFDA