BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOXT3 / NOXTURNAL T3 HOME SLEEP TESTING CLIN TECH

    MDR report key: 22348152 · Received June 26, 2025

    Report

    Report Number
    MW5172053
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    May 5, 2025
    Report Date
    June 23, 2025
    Manufacturer
    NOX MEDICAL
    Product Code
    MNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CHIEF COMPLAINT: I WENT TO THE DOCTOR ON YESTERDAY FOR SLEEP MEDICINE AND SHOWN ME HOW TO GIVE MYSELF A TEST AT HOME. LAST NIGHT THE EQUIPMENT GAVE ME AN ELECTRIC SHOCK. I HAVE A BURN ON MY CHEST, ON THE RIGHT SIDE. IT IS THE SIZE OF NICKEL. I HAVE A HEADACHE AND RIGHT SHOULDER HURT TOO. HEADACHE IN THE FRONT OF MY HEAD, PAIN IS 3-4 AND SHOULDER PAIN IS 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262398 NOXT3 / NOXTURNAL T3 HOME SLEEP TESTING CLIN TECH VENTILATORY EFFORT RECORDER MNR NOX MEDICAL 904013244

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other