BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURELIFE

    MDR report key: 8031593 · Received November 1, 2018

    Report

    Report Number
    3005798905-2018-02725
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 4, 2018
    Report Date
    November 1, 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 · 1

    HAVING READING PROBLEMS WITH HER WRIST BLOOD PRESSURE MONITOR. READ 199/94 BEFORE SHE WENT TO THE HOSPITAL, BUT SHE WAS READING 123/80 IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867951 SURELIFE WRIST BLOOD PRESSURE MONITOR DXN MHC MEDICAL PRODUCTS, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1