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 034 07 13 000
  • Fecha de inicio del evento
    2013-07-04
  • 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=5&rid=3882
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Causa
    Radiometer has recently become aware that one lot of membrane boxes has been produced using an incorrect electrolyte solution. some of these membranes have been found to calibrate and provide valid results on the analyzer for a few days (4-6 days), before cal 2 fails on zero point. when this happens the membrane units will have a rapidly increasing positive bias until they are rejected by the following cal 2. cal 2 is run every 4 hours, and within this time slot there is a possible risk of obtaining wrong measuring results.

Device

IVD: Blood gas electrode, oxygen, pO2 membrane units for ABL5/50/500
  • Modelo / Serial
    D999 Membrane box for E909 pO2 electrode for ABL5/50/5XX, 942-042, R0971
  • Descripción del producto
    An electrical conducting device used to determine the concentration of oxygen (O2) in a sample of blood
  • Manufacturer
    Radiometer Medical

Manufacturer

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