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 Radiometer Medical.

¿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 035 12 12 000
  • Fecha de inicio del evento
    2012-12-05
  • 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=2698
  • 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
    Radiometer have recently become aware that there is a potential risk of electrical shock for the operator. the electrical shock may appear under the following conditions: • the monitor is connected to the mains outlet and the mains switch is on • the battery is fully charged (or no battery is present) • the operator disconnects the line cord (at either end) without first switching the mains switch on the back of the monitor off • the operator touches the two metal pins on the mains plug or on the monitor’s line cord receptacle after disconnecting the line cord.

Device

Monitors, Bedside, Blood Gas, TCM4 series Base Unit
  • Modelo / Serial
    • All TCM4 series Base Units with serial numbers starting with: 000-154, 391-876, 391-878. • TCM4 series Base Unit with serial numbers of 391-880 below R0175N009. • Spare part Power Supply, 910-246.
  • Descripción del producto
    Monitors, Bedside, Blood Gas
  • Manufacturer
    Radiometer Medical

Manufacturer

Radiometer Medical
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Representante del fabricante
    Salehiya Trading Est., Riyadh, (01) 2628939
  • Source
    SFDA