BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE 3 LED PHOTOTHERAPY SYSTEM

    MDR report key: 6682371 · Received June 30, 2017

    Report

    Report Number
    3018859-2017-00367
    Event Type
    Malfunction
    Date Received
    June 30, 2017
    Report Date
    May 31, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K160305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NATUS TECHNICAL SERVICE MADE MULTIPLE ATTEMPTS TO CONTACT THE COMPLAINANT AFTER ADVISING THAT THE CONNECTION TO THE HIGH/LOW INTENSITY SWITCH SHOULD BE RESEATED AS AN INITIAL TROUBLESHOOTING STEP. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED BECAUSE NO RESPONSE TO THESE COMMUNICATIONS WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE NB USER MANUAL, PN 001364 REV. K, PROVIDES OPERATING INSTRUCTIONS IN CHAPTER 4 TO CHECK THE INTENSITY OF THE LIGHT USING A RADIOMETER PER THE INSTITUTION'S PROCEDURE (SEE SECTION 6.1). THE INTENSITY OF THE LIGHT WAS FACTORY CALIBRATED TO DELIVER 35 UW/CM2/NM AT THE HIGH SETTING AND 15 UW/CM2/NM AT THE LOW SETTING AT A DISTANCE OF 12 INCHES (30.5 CM) FROM THE BABY. DURING EVENT CALL TECHNICAL SERVICE REPRESENTATIVE ADVISED THE CUSTOMER TO RESEAT THE CONNECTION OF HIGH - LOW INTENSITY SWITCH, TO RESOLVE THE ISSUE. TECH SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER FOR THE STATUS OF THE DEVICE AFTER TROUBLESHOOTING, NATUS WILL PROVIDE SUPPLEMENTAL REPORT AS NEEDED.

    Description of Event or Problem · 1

    NATUS MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2017 THAT THEIR NEOBLUE 3 LED LIGHT HAD MOSTLY AMBER LEDS THAT WERE ILLUMINATING. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED THE CUSTOMER TO RESEAT THE CONNECTION OF HIGH - LOW INTENSITY SWITCH, TO RESOLVE THE ISSUE. 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
    461779 NEOBLUE 3 LED PHOTOTHERAPY SYSTEM NEOBLUE 3 LBI NATUS MEDICAL INCORPORATED 001103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other