BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE MINI LED PHOTOTHERAPY SYSTEM

    MDR report key: 7229679 · Received January 30, 2018

    Report

    Report Number
    3018859-2018-00080
    Event Type
    Malfunction
    Date Received
    January 30, 2018
    Report Date
    January 2, 2018
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K022196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT REPORTED THAT LIGHT INTENSITY WAS FOUND TO BE WITHIN SPECIFICATIONS ONCE THE REPLACEMENT CONSTANT CURRENT PCB WAS INSTALLED. THE NEOBLUE MINI UNIT WAS PLACED BACK IN SERVICE. THE COMPLAINANT ALSO CONFIRMED THAT THERE HAD BEEN NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INQUIRED ABOUT ORDERING INFORMATION FOR A REPLACEMENT LED PANEL AND CONSTANT CURRENT PCB, WHICH NATUS TECHNICAL SERVICE PROVIDED. NATUS RECEIVED A PURCHASE ORDER FOR A REPLACEMENT CONSTANT CURRENT PCB ON 1/5/2018, AND THE PART WAS DELIVERED TO THE COMPLAINANT ON 1/8/2018.

    Description of Event or Problem · 1

    NATUS RECEIVED A REPORT THAT THE INTENSITY OF A NEOBLUE MINI DEVICE COULD NOT BE ADJUSTED TO MEET SPECIFICATIONS. THE COMPLAINANT REPORTED INTENSITY OF 2-3 UW/CM^2/NM WHEN THE POTENTIOMETER WAS ADJUSTED TO ITS MAXIMUM SETTING. A NATUS NEOBLUE RADIOMETER (CALIBRATION DUE 10/2018) WAS USED TO MEASURE INTENSITY. THE NEOBLUE MINI SERVICE MANUAL STATES THAT THE LIGHT INTENSITY SPECIFICATION IS GREATER THAN OR EQUAL TO 30 UW/CM^2/NM 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
    70765 NEOBLUE MINI LED PHOTOTHERAPY SYSTEM NEOBLUE MINI LBI NATUS MEDICAL INCORPORATED 040823

    Patients

    Seq Age Sex Outcome Treatment
    1 Other