BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE 3

    MDR report key: 6867175 · Received September 14, 2017

    Report

    Report Number
    3018859-2017-00697
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Report Date
    August 17, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K160305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CUSTOMER WAS SENT A REPLACEMENT INTENSITY SWITCH FOR THE NEOBLUE. 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). SEVERAL ATTEMPTS WERE MADE TO THE CUSTOMER FOR THE STATUS OF THE DEVICE, WITH NO RESPONSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO NATUS ON (B)(6) 2017 THEIR NEOBLUE 3 HAD LED LIGHT INTENSITY SWITCH WAS DEFECTIVE. THE CUSTOMER DID NOT MENTION PATIENT INVOLVEMENT, OR ENVIRONMENTAL/SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646213 NEOBLUE 3 NEOBLUE LBI NATUS MEDICAL INCORPORATED 001103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other