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
    2016-12-02
  • 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
    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