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 Draeger Medical 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 138 09 12 000
  • Fecha de inicio del evento
    2012-09-16
  • 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=2393
  • 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
    Increasing numbers of cases in which significant quantities of compressed air escaped during generation of compressed air in the hospital. this was due to a failure of input valves in the ecopharm tower absorption dryer. in one case, both redundant dryers failed within 24 hours, resulting in a compressed air shortage warning on the hospital's wards. there has been no report of any failure of medical devices, nor of any personal injury.

Device

medical air, Compressed Air System and dryer
  • Modelo / Serial
    EcoPharm Tower MA DME 0125-805
  • Descripción del producto
    Compressed Air System
  • Manufacturer
    Draeger Medical Inc

Manufacturer

Draeger Medical Inc
  • Empresa matriz del fabricante (2017)
    Stefan Dräger GmbH
  • Representante del fabricante
    International Medical Development Co. Ltd.
  • Source
    SFDA