BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE 3 LED PHOTOTHERAPY SYSTEM

    MDR report key: 7229678 · Received January 30, 2018

    Report

    Report Number
    3018859-2018-00079
    Event Type
    Malfunction
    Date Received
    January 30, 2018
    Report Date
    January 2, 2018
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K160305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS TECHNICAL SERVICE ADVISED THE COMPLAINANT TO REPLACE THE CONSTANT CURRENT PCB, AND A REPLACEMENT CONSTANT CURRENT PCB WAS DELIVERED TO THE COMPLAINANT ON 1/8/2018. NATUS TECHNICAL SERVICE FOLLOWED UP WITH THE COMPLAINANT CONCERNING THE STATUS OF THE DEVICE ON 1/24/2018 AND 1/29/2018. NO RESPONSE WAS RECEIVED.

    Description of Event or Problem · 1

    NATUS RECEIVED A REPORT THAT THE INTENSITY OF A NEOBLUE 3 DEVICE (INSTALLED (B)(6) 2014) WAS BELOW SPECIFICATIONS. WHILE MEASURING 12" BELOW THE CENTER OF THE DEVICE, THE COMPLAINANT REPORTED INTENSITY READINGS OF 30 AND 26 UW/CM^2/NM ON THE HIGH SETTING AND 7 AND 12 UW/CM^2/NM ON THE LOW SETTING. A NATUS NEOBLUE RADIOMETER (CALIBRATED 8/2017) WAS USED TO MEASURE INTENSITY. THE NEOBLUE 3 SERVICE MANUAL STATES THAT THE LIGHT INTENSITY SPECIFICATION IS 35 ± 3.5 UW/CM^2/NM ON THE HIGH SETTING AND 15 ± 2 UW/CM^2/NM ON THE LOW SETTING AS MEASURED BY A NEOBLUE RADIOMETER. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, DELAY IN TREATMENT, OR ENVIRONMENTAL/SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70829 NEOBLUE 3 LED PHOTOTHERAPY SYSTEM NEOBLUE 3 LBI NATUS MEDICAL INCORPORATED 001103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other