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 042 12 17 000
  • Fecha de inicio del evento
    2017-12-12
  • 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=11875
  • 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
    Ge healthcare has recently become aware of a potential issue related to inaccurate manometer reading of lullaby resus plus devices when used for t-piece resuscitation. during the neonatal resuscitation process using t-piece on resus plus devices, the manometer shows higher peep reading than actual maintained at the end of t-piece. less than expected peep may lead to insufficient ventilation. there have been no injuries reported as a result of this issue.

Device

Lullaby Resus plus
  • Modelo / Serial
    All Lullaby RESUS Plus Systems -Part number: 2070100-001 (Lullaby Resus Plus - NIST) & 2070100-002 (Lullaby Resus Plus- DISS)
  • Descripción del producto
    T-piece resuscitation
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare