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 003 12 14 000
  • Fecha de inicio del evento
    2014-12-01
  • 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=6795
  • 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 mrx could contain incorrect internal software settings, causing the following two issues: 1. the device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended. 2. while connected to ac or dc power and with no battery installed or the battery installed has a charge level of less than 10%, the ready for use (rfu) indicator will not provide the expected low battery indication (flashing red x with audible chirp). instead, the rfu will show a flashing black hourglass, indicating that sufficient battery power is available for device operation.

Device

Philips HeartStart MRx Monitor/Defibrillator..
  • Modelo / Serial
    Product: Philips HeartStart MRx Monitor/Defibrillators Units Affected: MRx units, models M3535A and M3536A, with the following serial numbers: US00101159, US00533518, US00322848, US00533521 through US00535118, US00326834, US00539526, US00328432, US00540124, US00328439, US00543102, US00328442, US00543104, US00328443, US00543138, US00328446, US00543158, US00328450, US00543161, US00328461, US00543166, US00328464, US00543167, US00328465, US00543187, US00328468, US00543204, US00328473, US00543223, US00328478, US00543239, US00330393, US00546804
  • Descripción del producto
    Monitor/Defibrillator
  • Manufacturer
    Philips Healthcare

Manufacturer

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