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 Schiller AG.

¿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 048 01 16 000
  • Fecha de inicio del evento
    2016-01-13
  • 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=8770
  • 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
    Your fred easy is equipped with an internal battery, independent of the main battery (blue), which must be replaced every six years. this is described in the user guide, in the section "maintenance". the replacement of this battery every 6 years is compulsory, the proper function of your device depends of it. if this instruction is not observed, the device could become unable to start. this requires the intervention of qualified personnel, the disassembly is required.

Device

FRED easy
  • Modelo / Serial
    Begins the serial number of your FRED easy with 58xxxxxx (8 digits) or is your Serial number 058xx7)0000cx, 058xx8xx)ocxx, 058xx9xxxxxx (12 digits)
  • Descripción del producto
    Defibrillator
  • Manufacturer
    Schiller AG

Manufacturer

Schiller AG
  • Empresa matriz del fabricante (2017)
    Schiller Holding Ag
  • Representante del fabricante
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA