Events

Field Safety Notices about neoBLUE® blanket system performance

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Natus Medical Incorporated.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-10-12
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / 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