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 Datex - Ohmeda 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 014 10 18 000
  • Fecha de inicio del evento
    2018-10-07
  • 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=13262
  • 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
    Safety issue #1: upgraded aisys anesthesia devices and aisys cs2 anesthesia devices utilizing end-tidal control (etc mode) on rare occasions may lose ability to change fresh gas and agent settings when stopping the etc mode. safety issue #2: upgraded aisys anesthesia devices and aisys cs2 anesthesia devices with psvpro spontaneous breathing modes do not provide the psvpro ventilation mode feature of transitioning to simv pcv backup ventilation mode.

Device

Aisys and Aisys CS2 Anesthesia Devices
  • Modelo / Serial
    All upgraded Aisys anesthesia devices (i.e. Aisys devices upgraded to software version 11) and Aisys CS2 anesthesia devices (GTIN: 840682102292) with PSVPro option and/or End Tidal Control option. Software versions other than 11.00 and 11 SP01 are not affected.
  • Descripción del producto
    Anesthesia Units
  • Manufacturer
    Datex - Ohmeda Inc

Manufacturer

Datex - Ohmeda Inc