BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE

    MDR report key: 6824637 · Received August 28, 2017

    Report

    Report Number
    3018859-2017-00640
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Report Date
    August 1, 2017
    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

    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. REPLACEMENT LED PANEL WAS SHIPPED TO THE CUSTOMER AND TECH SUPPORT ADVICE 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 REPLACEMENT, 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 HAD LED BOARD 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
    604429 NEOBLUE NEOBLUE 3 LBI NATUS MEDICAL INCORPORATED 001103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other