BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURELIFE ARM BP MONITOR-PREMIUM

    MDR report key: 7617414 · Received June 19, 2018

    Report

    Report Number
    3005798905-2018-02436
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    January 30, 2018
    Report Date
    June 18, 2018
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    DXN
    PMA / PMN Number
    K091434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MONITOR IS GIVING FALSE READINGS. CUSTOMER WENT TO HIS DOCTOR'S OFFICE TO DOUBLE-CHECK, AND HIS READINGS ARE OFF WHEN USING THE MONITOR. NORMAL BLOOD PRESSURE IS 140/78-82, BUT THE MONITOR RESULTS ARE 165-170/100-103.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455675 SURELIFE ARM BP MONITOR-PREMIUM SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE DXN MHC MEDICAL PRODUCTS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1