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 Medizin Systeme GmbH..

¿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 004 09 17 000
  • Fecha de inicio del evento
    2017-09-03
  • 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=11481
  • 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
    During 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. investigation indicates this is typically seen prior to initial use or during set-up, but the clamping could also deteriorate over time. the product has not been involved with any reported injuries, and there are no known safety risks related to it. as a reminder, the universal arm support is used to position and restrain a patient’s arm securely during surgery, as well as the induction and recovery phases.

Device

Universal Arm Support
  • Modelo / Serial
    Product Name Model Number up to serial number Universal Arm Support 450 1697630 103106579 Universal Arm Support 450 T 1697635 103011318 Universal Arm Support 600 1697639 102631713 Universal Arm Support 600 T 1697651 102968819 Universal Arm Support 450 U 1697660 102956866 Universal Arm Support 450 U T 1697662 102945650
  • Descripción del producto
    Arm Support
  • Manufacturer
    TRUMPF Medizin Systeme GmbH.

Manufacturer

TRUMPF Medizin Systeme GmbH.
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Representante del fabricante
    Medical regulations gate
  • Source
    SFDA