BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE 3 LED PHOTOTHERAPY SYSTEM

    MDR report key: 6746461 · Received July 27, 2017

    Report

    Report Number
    3018859-2017-00520
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Report Date
    June 28, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K160305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REPLACEMENT NEOBLUE 3 LED PANEL WAS SHIPPED TO THE COMPLAINANT. ON MULTIPLE OCCASIONS, NATUS TECHNICAL SERVICE REQUESTED RETURN OF THE LED PANEL INVOLVED IN THE COMPLAINT AND INQUIRED WHETHER THE ISSUE WAS RESOLVED BY INSTALLATION OF THE REPLACEMENT LED PANEL. NO RESPONSE FROM THE COMPLAINANT WAS RECEIVED. PROBABLE CAUSE OF THE REPORTED ISSUE WAS ASSIGNED AS A FAILURE OF THE LED PANEL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO HALF-COLUMNS AND ONE FULL COLUMN OF YELLOW LEDS WERE NOT ILLUMINATING ON THE LED PANEL OF THE NEOBLUE 3 UNIT, AND SOMETIMES ALL OF THE BLUE LEDS WOULD NOT ILLUMINATE ON THE LED PANEL.

    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. THE CAUSE CODE FOR THE ISSUE WAS FOUND, HOWEVER PRODUCT RETURN IS REQUESTED FOR L2 INVESTIGATION. 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 (PN # 001103, SN # (B)(4), INSTALLED: (B)(6) 2015, TIMER READING: 892 HOURS) HAD LED FAILURE. 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
    528326 NEOBLUE 3 LED PHOTOTHERAPY SYSTEM NEOBLUE 3 LBI NATUS MEDICAL INCORPORATED 001103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other