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 123 02 18 000
  • Fecha de inicio del evento
    2018-02-26
  • 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=12202
  • 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
    Philips has become aware of a specific issue with one of the electric components (a resistor) in approximately 660,000 aeds that were manufactured between 2002-2013. virtually all of these resistor-related failures were detected through the device’s automatic self-testing, alerting the user by issuing audible chirps. the in-use reliability of these aeds is greater than 99.9% when the aed determines a cardiac arrest victim is in need of shock therapy. however, in rare instances, self-tests might not identify a problem and the device might not deliver a shock when needed. to date, philips is aware of 13 instances in which this component failed during treatment, out of more than 45,000 uses in which shock therapy was delivered. in all these instances, the device delivered at least one shock before failure. among the cases for which the patient outcome is known, 5 patients died and 2 patients were successfully resuscitated and survived. importantly, when aeds are used on patients suffering sudden cardiac arrest, not all patients survive. in published studies of public access defibrillation to treat sudden cardiac arrest, the typical indicated survival rates are approximately 25% when an aed is used by a bystander versus 10% if an aed is not used.

Device

HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs
  • Modelo / Serial
    Philips AED Models: HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs manufactured from September 2002 through February 2013 are included within the scope of this notification because they may contain the type of resistor that has previously been associated with a failure. The year of manufacture can be identified by the 2nd and 3rd characters in the serial number on the back of the AED in the range: Home/Onsite:(02)I-xxxxx through A 13(B-)xxxxx FRxB(04)L-xxxxx through B13(B-)xxxxx
  • Descripción del producto
    Defibrillator/Cardioverters
  • Manufacturer
    Philips Healthcare

Manufacturer

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