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 C R Bard 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 039 08 17 000
  • Fecha de inicio del evento
    2017-08-15
  • 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=11405
  • 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
    Bard is issuing a field safety notice to advise users of an update to the instructions for use for the arctic sun® 5000 temperature management system, per the enclosed labelling addendum. this labelling addendum should be used together with the current operator’s manual and service manual for your device and will be included in the labelling of all future units distributed by bard. the labelling addendum advises that periodic servicing and maintenance of the arctic sun® 5000 temperature management system is recommended to reduce the risk of failure of certain components.

Device

ARCTIC SUN® 5000 Temperature Management System
  • Modelo / Serial
    Product Codes: 5000-01-01, 5000-01-02, 5000-01-07, 5000-01-08
  • Descripción del producto
    Warming/Cooling Units, Patient
  • Manufacturer
    C R Bard Inc

Manufacturer

C R Bard Inc