BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE 3

    MDR report key: 6863348 · Received September 13, 2017

    Report

    Report Number
    3018859-2017-00687
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Report Date
    August 15, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K160305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE ISSUE WAS VERIFIED BY NATUS TECH SUPPORT OVER THE PHONE WITH THE CUSTOMER. 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 [?]W/CM2/NM AT THE HIGH SETTING AND 15 [?]W/CM2/NM AT THE LOW SETTING AT A DISTANCE OF 12 INCHES (30.5 CM) FROM THE BABY. INTENSIVE PHOTOTHERAPY (>30 [?]W/CM2/NM), MAY NOT BE APPROPRIATE FOR ALL INFANTS (I.E. PRETERM INFANTS [?]1000G). TROUBLESHOOTING WAS PERFORMED BY THE BIOMEDICAL TECHNICIAN AND ADDITIONAL PRODUCT EXAMINATION IS NOT NECESSARY TO DETERMINE THE CAUSE. CONFIRMED BY THE CUSTOMER, NO FURTHER INVESTIGATIONS NEEDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO NATUS ON (B)(6) 2017 THEIR NEOBLUE 3 HAD LED LIGHT WERE FLICKERING AMBER COLORS WHEN BUMPED. 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
    642454 NEOBLUE 3 NEOBLUE LBI NATUS MEDICAL INCORPORATED 001103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other