BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE 3

    MDR report key: 6734789 · Received July 21, 2017

    Report

    Report Number
    3018859-2017-00502
    Event Type
    Malfunction
    Date Received
    July 21, 2017
    Report Date
    June 23, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K160305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER SENDING A REPLACEMENT INTENSITY SWITCH, NO FURTHER COMMUNICATION FROM THE COMPLAINANT WAS RECEIVED. PROBABLE CAUSE FOR THE EVENT WAS ASSIGNED AS A FAILURE OF THE INTENSITY SWITCH.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE ISSUE WAS VERIFIED BY NATUS TECH SUPPORT OVER THE PHONE WITH THE CUSTOMER. THE INTENSITY SWITCH WAS REPLACED. THE PRODUCT WAS INSTALLED IN (B)(6) 2014, THEREFORE A MANUFACTURING DEFECT IS NOT LIKELY TO HAVE CAUSED THE SWITCH FAILURE. TECH SUPPORT ATTEMPTED TO FOLLOW-UP WITH THE CUSTOMER AND RECEIVED NO RESPONSE. 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). INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO NATUS ON JUNE 23RD, 2017 THAT THEIR NEOBLUE 3 (PN # 001103, SN # (B)(4), INSTALLED ON (B)(6) 2014) LED LIGHT HAD BLUE LEDS THAT WERE FLICKERING. THERE WAS NO REPORT OF HARM, DEATH OR SERIOUS INJURY. NO REPORT OF MEDICAL INTERVENTION. NO ENVIRONMENTAL OR SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513871 NEOBLUE 3 NEOBLUE 3 LED PHOTOTHERAPY SYSTEM LBI NATUS MEDICAL INCORPORATED 001103

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O