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
    2016-12-02
  • 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
    This notification is related to a prior notification and technical bulletin that you received around march 2015 regarding the neoblue blanket led phototherapy system. at that time, natus informed you of a potential issue of discoloration/degradation/melting of the fiber optic bundle at the pad connector which is inserted in the neoblue blanket light box. included with that letter was a technical bulletin which described the issue and addressed many of your potential questions. natus is in the process of confirming an updated neoblue blanket configuration which will not be susceptible to the degradation described above. however, the date of project completion is uncertain at this time. natus will contact you when the new configuration is available, at which time we intend to initiate a field corrective action to replace or upgrade your device(s). .

Device

neoBLUE® blanket system performance

Manufacturer

Natus Medical Incorporated