Events

Field Safety Notices about neoBLUE® blanket system fiber optic pads

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.

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
  • 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
    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