BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE 3 LED PHOTOTHERAPY SYSTEM

    MDR report key: 6802611 · Received August 17, 2017

    Report

    Report Number
    3018859-2017-00591
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Report Date
    July 18, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K160305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A LIST OF QUESTIONS REGARDING THE ISSUE WAS DEVELOPED AS PART OF THE COMPLAINT INVESTIGATION. NATUS TECHNICAL SERVICE CONTACTED THE COMPLAINANT MULTIPLE TIMES IN ORDER TO HAVE THESE QUESTIONS ANSWERED, BUT NO RESPONSE WAS RECEIVED. INFORMATION THAT WAS ASKED FOR INCLUDED: A PICTURE OF THE NEOBLUE AND THE CRIB AS IT WAS POSITIONED DURING TREATMENT. RECTAL TEMPERATURE OF THE PATIENT AND AMBIENT TEMPERATURE DURING TREATMENT. DISTANCE BETWEEN THE NEOBLUE UNIT AND THE PATIENT. WHETHER A RADIANT WARMER WAS USED IN CONJUNCTION WITH THE NEOBLUE. SERIAL NUMBER OF THE NEOBLUE 3 UNIT. PATIENT HEALTH STATUS BEFORE AND AFTER THE EVENT. BECAUSE ANSWERS WERE NOT PROVIDED TO ANY FOLLOW-UP QUESTIONS, THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    NATUS MEDICAL HAS LAUNCHED AN INVESTIGATION. TECH SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER FOR ADDITIONAL INFORMATION. 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 , THE FAN WAS BLOWING TOO COLD ON THE BABY. THEY HAD TO REMOVE THE BABY FROM THE DEVICE DUE TO THE COLD AIR AND PUT IT UNDER A WARMER FOR A 1/2 HOUR. THE CUSTOMER CONFIRMED THERE WAS NO DEATH/SERIOUS INJURY, OR ENVIRONMENTAL/SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581287 NEOBLUE 3 LED PHOTOTHERAPY SYSTEM NEOBLUE 3 LBI NATUS MEDICAL INCORPORATED 001103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other