BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUALBEAT

    MDR report key: 12719465 · Received October 28, 2021

    Report

    Report Number
    MW5105021
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    October 25, 2021
    Report Date
    October 27, 2021
    Manufacturer
    SHENZHEN VIATOM TECHNOLOGY CO., LTD.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WEARING THE WELLUE VISUALBEAT DEVICE, IT STARTED READING A VERY HIGH AND THEN A VERY LOW AND ULTIMATELY A COMPLETELY UNRELIABLE HEART RATE. I KNOW IT'S A SMALL THING BUT I HAVE AN ISSUE WITH MY HEART. WHEN I SEE MY HEART RATE FLUCTUATING WILDLY IN THE MIDDLE OF A WORKOUT, IT CAUSES A LOT OF ANXIETY, MY HEART RACES AND I GET INTO THIS FEEDBACK LOOP. I SUSPECT THE WELLUE DEVICE WAS MALFUNCTIONING BECAUSE THE ELECTRIC MONITOR ON EXERCISE EQUIPMENT AND THE OPTICAL MONITOR ON A FITNESS TRACKER ON MY WRIST MEASURED A NORMAL HEART RATE. SUBSEQUENT MEASUREMENTS MADE WITH THE VISUALBEAT DEVICE CONFIRMED THAT THE DEVICE WAS FAILING. THE DEVICE HAS BEEN IN USE FOR ABOUT 6 MONTHS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614335 VISUALBEAT ELECTROCARDIOGRAPH DPS SHENZHEN VIATOM TECHNOLOGY CO., LTD. EP1

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Disability