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 046 02 18 000
  • Fecha de inicio del evento
    2018-02-13
  • 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=12122
  • 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
    Specifically, in-use experience and limited testing has revealed that the previously communicated disinfection methods may not always be effective when used in connection with procedures that have long tee probe intubation times, such as cardiac surgeries, and/or with tee probes with visible signs of wear or damage in areas to be disinfected, both of which may increase the bioburden on the probe. under these conditions, ge recommends the use of a sterile sheath covering the tee probe in addition to disinfection using the soak based disinfecting method or the tristel trio wipes system as described below.(see attached fsn).

Device

GE TEE probes used with Tristel Trio Wipes System
  • Modelo / Serial
    GE TEE probes used with Tristel Trio Wipes System The following TEE probe models: 6VT-D, 6Tc, 6Tc-RS, 6T, 6T-RS, 9T and 9T-RS. (See Attached FSN for full details)
  • Descripción del producto
    Transducer assembly
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare