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 Philips Medical Systems.

¿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 106 10 18 000
  • Fecha de inicio del evento
    2018-10-21
  • 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=13358
  • 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
    Kv/ma lockin not functioning as specified: the lock-in function is a fluoroscopy only function. when this function is enabled, the current radiation parameters, (kv and ma values), are retained to keep a consistent image impression. this is relevant for examinations of anatomies such as knee or shoulder, where the amount of dose at the detector is strongly influenced by the amount of direct radiation. due to a software bug, the ma values are not locked, but increase when the operator restarts pulsed fluoroscopy several times after activation of the lock-in function. as a result, the patient received an increased radiation dose stitching with skyplate aborts after first image: if there is an improper synchronization between the skyplate detector and the system, the preview offset image will have artifacts. if this happens, the system software identifies the preview image buffer as not usable during the first part image acquisition of the stitching run and as a result will abort the run. the stitching run has to be repeated.

Device

CombiDiagnost,
  • Modelo / Serial
    All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2
  • Descripción del producto
    CombiDiagnost
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Empresa matriz del fabricante (2017)
    Philips
  • Representante del fabricante
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA