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 GE Healthcare.

¿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 027 11 11 000
  • Fecha de inicio del evento
    2011-11-09
  • 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=1001
  • 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
    The carescape monitor b650 may freeze in the middle of the start-up sequence, or enter into a continuous reboot cycle, preventing the normal use of the patient monitor. this may happen during monitor start-up by the operator or during patient monitoring. the carescape monitor b650 may lose audible alarms and qrs beep tone if the monitor is connected to an external information or data collection system via a usb port, and the user disconnects the usb cable from the patient monitor. in this situation, the monitor does not provide any indication that it cannot sound audible alarms. the audible alarms are re-enabled only after the monitor has been manually restarted by the operator.

Device

Electrocardiography, CARESCAPE Monitor
  • Modelo / Serial
    Model: B650 V1.1.8 and earlier
  • Descripción del producto
    Monitors, Bedside, Electrocardiography
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare