BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART WATCH HEALTHY SPORT HEART RATE

    MDR report key: 20587240 · Received October 31, 2024

    Report

    Report Number
    MW5162024
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Report Date
    October 25, 2024
    Manufacturer
    UNKNOWN
    Product Code
    QDA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THERE IS A WATCH COMPANY (VITAITY WATCHES LLC) THAT IS MAKING CLAIMS THAT THEIR PRODUCT (SMARTWATCH) CAN PERFORM AN EKG, TEST BLOOD PRESSURE, HEMOGLOBIN A1C, AND VARIOUS OTHER MEDICAL TESTS THAT IT COULDN'T POSSIBLY DO WITH ANY LEVEL OF ACCURACY. I AM FEARFUL THAT THIS PRODUCT IS DANGEROUSLY MISLEADING CUSTOMERS WHO WOULD; WITHIN REASON, USE THIS PRODUCT AS A DIAGNOSTIC DEVICE. MY MOTHER BOUGHT THIS DEVICE TO MONITOR HER HEART CONDITION AND WITHOUT MY INTERVENTION WOULD HAVE CONTINUED TO BELIEVE THAT HER HEART RHYTHM WAS NORMAL WHEN IT CATEGORICALLY WAS NOT. I BELIEVE THAT WITHOUT THE FDA'S INTERVENTION THIS PRODUCT WILL LEAD TO SERIOUS BODILY HARM OR DEATH OF A TRUSTING CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461672 SMART WATCH HEALTHY SPORT HEART RATE ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE QDA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female