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 Arjo Huntleigh.

¿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 082 05 13 000
  • Fecha de inicio del evento
    2013-05-21
  • 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=3638
  • 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
    The manufacturer conducted field safety correction actions in canada between 2004 and 2007 to provide improved safety instructions and warnings to reduce the risk of the alenti chair tipping and patient falls. the incident rate has since declined. however, the manufacturer continues to receive several incident reports in canada each year. since august 2012, there have been nine tipping and patient slide-out incidents reported in canada. two of these were associated with patient deaths ( more details in attached file ).

Device

Integrated bathing system, Alenti
  • Modelo / Serial
    SN : CDB8003-01, CDB8053-01, CDB8103-01, CDB8153-01
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Descripción del producto
    Part of an integrated bathing system, Alenti™ provides transport and transfer solution for semi-dependent residents.
  • Manufacturer
    Arjo Huntleigh

Manufacturer

Arjo Huntleigh
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Representante del fabricante
    Al-Faisaliah Medical System
  • Source
    SFDA