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 Heinen & Loewenstein.

¿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 143 09 12 000
  • Fecha de inicio del evento
    2012-09-19
  • 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=2398
  • 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
    During the uninterrupted operation of the leoni plus for more than 49 consecutive days the device may start a highest priority alarm that results in a continuous alarm sound and a visual alarm on the monitor. as a consequence of this the ventilation will be interrupted preventing potential hazards for the patient. this situation is just a potential scenario that may appear in rare cases where the devices are continuously operated and put into the standby mode during periods not being connected to the patient but never shut down completely during a period of 49 days.

Device

Ventilator, neonatal/paediatric, Leoni plus
  • Modelo / Serial
    Serial no.: 0217001xxx, 0217004xxx; Software Version 1.x.x and 2.2.x.;
  • Descripción del producto
    Ventilator, neonatal/paediatric
  • Manufacturer
    Heinen & Loewenstein

Manufacturer

Heinen & Loewenstein
  • Empresa matriz del fabricante (2017)
    Löwenstein Familien-Stiftung
  • Representante del fabricante
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA