Events

Notificaciones De Seguridad De Campo acerca de neoBLUE® blanket system fiber optic pads

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Natus Medical.

¿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
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Natus medical has received feedback from some customers about early failure of the neoblue® blanket system fiber optic pads. these failures involve discoloration/degradation followed by eventual melting of the fiber optic bundle at the connector that is inserted in the neoblue blanket light box. natus’ investigations have shown that this failure occurs after extended exposure to the intense light source within the box, at which time the pad no longer provides the therapeutic treatment for which it is intended. following the guidelines of this technical bulletin will help to prevent failures from occurring on customer systems. .

Device

neoBLUE® blanket system fiber optic pads

Manufacturer

Natus Medical