BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURELIFE

    MDR report key: 7679854 · Received July 11, 2018

    Report

    Report Number
    3005798905-2018-00685
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 12, 2018
    Report Date
    July 11, 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
    003

    Narratives

    Description of Event or Problem · 0

    MACHINE IS GIVING HIGH READINGS AND WANTED TO KNOW IF HE NEEDED TO CHANGE THE BATTERIES.

    Description of Event or Problem · 1

    MACHINE IS GIVING HIGH READINGS AND WANTED TO KNOW IF HE NEEDED TO CHANGE THE BATTERIES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522081 SURELIFE BLOOD PRESSURE MONITOR DXN MHC MEDICAL PRODUCTS, LLC. 43895

    Patients

    Seq Age Sex Outcome Treatment
    1