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 Terumo Cardiovascular Systems Corporation.

¿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 154 07 18 000
  • Fecha de inicio del evento
    2018-07-31
  • 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=12995
  • 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
    Specific subset of the h/sat probe assembly population is being withdrawn due to a supplied component in the optics, the optical module. a change by the supplier to a different material and anodization resulted in increased failures. h/sat probe assemblies are used in production and in service. the cdi system 500 monitor conducts an automated self-test when the device is powered on. if the monitor contains an affected component, a color chip test failure will occur and the h/sat probe will be disabled.

Device

CDI Blood Parameter Monitoring System 500 H/Sat Probe Assembly
  • Modelo / Serial
    HSat Probe Assembly, CDI 500 : 145883 Monitor with one Blood Parameter Module and one HSat Probe : 500AHCT Monitor with two Blood Parameter Modules and one HSat Probe : 500AVHCT
  • Descripción del producto
    Continuous bloodparameter monitoringfor improved bloodgas management
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Representante del fabricante
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA