BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE LIFE

    MDR report key: 7932840 · Received October 3, 2018

    Report

    Report Number
    3005798905-2018-02686
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    September 5, 2018
    Report Date
    September 7, 2018
    Manufacturer
    MHC MEDICAL PRODCUTS, LLC.
    Product Code
    DXN
    PMA / PMN Number
    K091434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    MONITOR IS READING INACCURATELY COMPARED TO OTHER DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773356 SURE LIFE BLOOD PRESSURE MONITOR DXN MHC MEDICAL PRODCUTS, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1