Events

Avis De Sécurité sur neoBLUE® blanket system performance

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Natus Medical Incorporated.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-10-12
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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