Events

Notificaciones De Seguridad De Campo acerca de neoBLUE® blanket system performance

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 Incorporated.

¿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
  • Fecha
    2016-10-12
  • 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
    The neoblue blanket system you received included the reliability update to prevent the potential early degradation and melting of the fiberoptic bundle at the pad connection to the neoblue blanket light box. this reliability update was intended to prevent the previous discoloration and melting, and natus wants to ensure that you do not experience any further issues. .

Device

neoBLUE® blanket system performance
  • Modelo / Serial
    006244 neoBLUE blanket LED Phototherapy System with Large blanket/pad; US power cord 006895 neoBLUE blanket LED Phototherapy System with Small blanket/pad; US power cord 007299 neoBLUE blanket LED Phototherapy System with Large blanket/pad; EU power cord 007300 neoBLUE blanket LED Phototherapy System with Small blanket/pad; EU power cord 007296 neoBLUE blanket LED Phototherapy System with Large blanket/pad; UK power cord 007298 neoBLUE blanket LED Phototherapy System with Small blanket/pad; UK power cord 007301 neoBLUE blanket LED Phototherapy System with Large blanket/pad; AUS power cord 007302 neoBLUE blanket LED Phototherapy System with Small blanket/pad; AUS power cord
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated