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 033 11 18 000
  • Fecha de inicio del evento
    2018-11-12
  • 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=13476
  • 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
    Certain mrx m3538a lithium-ion batteries may contain a defective component should the component fail, the battery will no longer charge or deliver power to the mrx monitor/defibrillator, which may prevent operation of the device if a second charged battery is not installed or if the device is not connected to ac or dc power. additionally, the led status indicator on the battery will not illuminate, even if the battery has a charge. should a second, unaffected battery be present in the heart5tart mrx, the battery failure may go unnoticed.

Device

Philips HeartStart MRx M3538A
  • Modelo / Serial
    Product: M3538A Lithium-Ion Batteries for the HeartStart MRx Monitor/Defibrillator Units Affected subject to thi5 Recall: A total of 1,880 Lithium-Ion Batteries manufactured between January 1gth, 2018 and March 20th, 2018 with serial numbers 17362-0001-P through 18057-0266-P
  • Descripción del producto
    Patient Monitoring
  • Manufacturer
    Philips Healthcare

Manufacturer

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