BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE 3

    MDR report key: 6779037 · Received August 9, 2017

    Report

    Report Number
    3018859-2017-00559
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Report Date
    July 11, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K160305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEOBLUE USER MANUAL, 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. TECH SUPPORT VERIFIED THE PROBLEM. NATUS FACTORY SERVICE REPAIRED AND REPLACED PCBA PN # 040929, RESOLVED DEVICE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO NATUS ON (B)(6) 2017 THAT THEIR NEOBLUE 3 LED LIGHT HAD ALL AMBER LEDS ILLUMINATING SPORADICALLY. THERE WAS NO REPORT OF HARM, DEATH OR SERIOUS INJURY. NO REPORT OF MEDICAL INTERVENTION. NO ENVIRONMENTAL OR SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557554 NEOBLUE 3 NEOBLUE BLANKET LBI NATUS MEDICAL INCORPORATED 001103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other