BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-INVASIVE VITAL SIGN OMNITRAK

    MDR report key: 85546 · Received July 1, 1996

    Report

    Report Number
    85546
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    April 11, 1996
    Report Date
    April 12, 1996
    Manufacturer
    INVIVO RESEARCH, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    MRI WAS PERFORMED ON SEDATED PT ON 4/11/96. NON-INVASIVE CARDIAC MONITOR WAS USED. ELECTRODES WERE USED WITH MONITOR. FOUR ELECTRODES WERE PLACED ON THE PT. IMMEDIATELY POST MRI, ELECTRODES WERE REMOVED AND PT'S SKIN WAS ASSESSED. 3 REDDENED AREAS THE SIZE OF THE ENTIRE ELECTRODE WERE NOTED AND THE FOURTH ELECTRODE WAS OFF PT. HOWEVER, PRIOR TO THE PROCEDURE, THE STAFF WAS CERTAIN THAT ALL 4 ELECTRODES WERE PLACED SECURELY ON PT AND THE WIRES WERE NOT CROSSED. SOON AFTER INITIAL ASSESSMENT, REDDENED AREAS APPEARED TO BE BURNS. PT WAS PERSPIRING SLIGHTLY POST MRI. PT HAD NO ALLERGIES TO TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-INVASIVE VITAL SIGN OMNITRAK CARDIAC MONITOR DRT INVIVO RESEARCH, INC. 3100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention #M 3M RED DOT ELECTRODES #2246