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 Physio-Control 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 031 05 18 000
  • Fecha de inicio del evento
    2018-05-09
  • 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=12582
  • 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
    Physio-control has become aware of an issue where the etco2 reading can intermittently show a value of “xxx” after start-up or during device operation. during the investigation, the manufacturer of the etco2 module found that compressed air may have contaminated filters within in the etco2 module. as a result of the contamination of the filter, the etco2 display on the lifepak 12 or lifepak 15 will provide a reading of “xxx”. there may be solid or dashed lines present on the device display in the place of an etco2 waveform and the service led will be illuminated. in this situation, the etco2 monitoring functionality will no longer be available.

Device

LIFEPAK® 15 and LIFEPAK® 12 with End-Tidal CO2 option
  • Modelo / Serial
    LIFEPAK® 15 Monitor/Defibrillator and LIFEPAK® 12 Defibrillator/Monitor with End-Tidal CO2 option
  • Descripción del producto
    Monitor/Defibrillator
  • Manufacturer
    Physio-Control Inc.

Manufacturer

Physio-Control Inc.
  • Empresa matriz del fabricante (2017)
    Stryker
  • Representante del fabricante
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA