BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12 LEAD ECG MONITOR

    MDR report key: 12049024 · Received June 23, 2021

    Report

    Report Number
    12049024
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 18, 2021
    Report Date
    May 20, 2021
    Manufacturer
    GENERAL ELECTRIC CO.
    Product Code
    DXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HERE FOR A SCHEDULED TREADMILL ECHO STRESS TEST. PATIENT STARTED TEST WITHOUT DIFFICULTY AND THEN BEGAN REPORTING SHARP, PINCHING PAIN TO RIGHT HIP AREA AFTER WALKING ON THE TREADMILL AFTER 6MIN. TREADMILL STOPPED PER RN, AND FOUND ECG 12 LEAD MONITOR BOX WITH PLASTIC SEPARATED FROM MONITOR BELTED AROUND PATIENT'S WAIST. MONITOR FOUND PINCHING PATIENT'S RIGHT FLANK AREA. SKIN, SLIGHTLY RED, INTACT, AND WITHOUT BRUISING. ECG MONITOR REMOVED FROM PATIENT'S HIP, NEW MONITOR APPLIED TO PATIENT'S WAIST, AND TIME RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949596 12 LEAD ECG MONITOR TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE DXH GENERAL ELECTRIC CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 28105 DA