BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE LIFE

    MDR report key: 7580493 · Received June 7, 2018

    Report

    Report Number
    3005798905-2018-00575
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    May 7, 2018
    Report Date
    June 7, 2018
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC.
    Product Code
    DXN
    PMA / PMN Number
    K091415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    INCORRECT READINGS BPM READINGS AREN'T READING CORRECTLY. 200/140 AND THAT IS NOT NORMAL.

    Description of Event or Problem · 1

    INCORRECT READINGS BPM READINGS AREN'T READING CORRECTLY. 200/140 AND THAT IS NOT NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422122 SURE LIFE BLOOD PRESSURE MONITORI DXN MHC MEDICAL PRODUCTS, LLC. 43892

    Patients

    Seq Age Sex Outcome Treatment
    1