Events

Notificaciones De Seguridad De Campo acerca de HeartWare Controller

Según Swiss Agency for Therapeutic Products, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Switzerland que fue producido por HeartWare.

¿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
    Field Safety Notice
  • ID del evento
    Vk_20130611_03
  • Fecha de publicación del evento
    2013-06-24
  • País del evento
    Switzerland
  • Fuente del evento
    SATP
  • URL de la fuente del evento
    https://fsca.swissmedic.ch/mep/#?q=Vk_20130611_03
  • Notas / Alertas
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Notas adicionales en la data

Device

HeartWare Controller
  • Modelo / Serial
    Model: 1400, 1408. Catalogue number: 1401xx, 1407xx. | All serial Numbers
  • Descripción del producto
    AIMD: Artificial heart, temporary
  • Manufacturer
    HeartWare

Manufacturer

HeartWare
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    SATP