BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE 3

    MDR report key: 6802612 · Received August 17, 2017

    Report

    Report Number
    3018859-2017-00588
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Report Date
    July 18, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K160305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS TECH SUPPORT OVER THE PHONE WITH THE CUSTOMER CONFIRMED THE ISSUE. THE NB USER MANUAL, PN 001364 REV. K, PROVIDES OPERATING INSTRUCTIONS TO CHECK THE INTENSITY OF THE LIGHT USING A RADIOMETER PER THE INSTITUTION'S PROCEDURE. THE INTENSITY OF THE LIGHT WAS FACTORY CALIBRATED TO DELIVER 35 [?]W/CM2/NM AT THE HIGH SETTING AND 15 [?]W/CM2/NM AT THE LOW SETTING AT A DISTANCE OF 12'' FROM THE BABY. THE RESEATING OF CONNECTOR OF THE DEVICE SOLVED THE CUSTOMER ISSUE. CONFIRMED BY THE CUSTOMER, NO FURTHER INVESTIGATIONS NEEDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO NATUS ON (B)(6) 2017 THEIR NEOBLUE 3 HAD LED LIGHTS WERE ALL GREEN WITH LOW INTENSITY. THE CUSTOMER CONFIRMED THERE WAS NO DEATH/SERIOUS INJURY, DELAY IN TREATMENT, OR ENVIRONMENTAL/SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581288 NEOBLUE 3 NEOBLUE LBI NATUS MEDICAL INCORPORATED 001103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other