BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE

    MDR report key: 6839657 · Received September 1, 2017

    Report

    Report Number
    3018859-2017-00657
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Report Date
    August 8, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K160305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS MEDICAL TECH SUPPORT FOLLOW-UP CONFIRMED THE CUSTOMER WAS ABLE TO TROUBLESHOOT THE ISSUE AND THE DEVICE OUTPUT INTENSITY WITHIN SPECIFICATION ONSITE. THE NB USER MANUAL, PN 001364 REV. K, STATES UNDER SECTION 1.2 THAT LEDS HAVE MINIMAL LIGHT OUTPUT DEGRADATION OVER THEIR LIFETIME WITH PROPER USE. NEVERTHELESS, THE USER CAN ADJUST THE OUTPUT OF THE LEDS FOR ANY DEGRADATION USING THE TWO POTENTIOMETERS. PRODUCT RETURN NOT REQUIRED FOR THIS 2-YEAR-OLD DEVICE FURTHER EXAMINATION. NO FURTHER EVALUATION IS NEEDED.

    Description of Event or Problem · 1

    NATUS MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2017 THAT THEIR NEOBLUE 3 BLUE LED LIGHTS WERE OUT OR NOT ILLUMINATING ON THE LED PANEL. 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
    619626 NEOBLUE NEOBLUE 3 LBI NATUS MEDICAL INCORPORATED 001103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other