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 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 114 01 13 000
  • Fecha de inicio del evento
    2013-01-28
  • 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=2950
  • 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 philips heartstart xl+ defibrillator/monitor may fail to power on in clinical mode and instead, power on in service mode displaying an “equipment disabled: therapy” prompt, requiring the user to enter a password and perform an operational check to clear the condition. the device will not return to clinical mode until an operational check is performed.

Device

Philips HeartStart XL+ Defibrillator/Monitor
  • Modelo / Serial
    model number 861290 Units Affected: Units manufactured by Philips from October, 2011 to January 2013, and shipped worldwide with serial numbers within the ranges: USO1100100 – USO1100372 USN1100376 – USN1100960 USD1100961 – USD1101095 US11201096 – US11201186 US21201187 – US21201239 US31201240 – US31201537 US41201538 – US41201585 US51201586 – US51201721 US61201722 – US61201924 US71201925 – US71202048 US81202049 – US81202168 US91202169 – US91202514 USO1202515 – USO1202990 USN1202991 – USN1203537 USD1203538 – USD1203968 US11303969 – US11303972
  • Descripción del producto
    Defibrillator/Monitor
  • Manufacturer
    Philips Healthcare

Manufacturer

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