BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-INVASIVE VITAL SIGN OMNI TRAK

    MDR report key: 85527 · Received July 1, 1996

    Report

    Report Number
    85527
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    January 29, 1996
    Report Date
    February 26, 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 PT ON 1/29/96. PT WAS SEDATED FOR MRI. NON-INVASIVE CARDIAC MONITOR PLACED ON PT. ELECTRODES WERE USED WITH CARDIAC MONITOR. FOUR ELECTRODES PLACED ON PT. IMMEDIATELY POST-MRI ELECTRODES WERE REMOVED AND PT'S SKIN ASSESSED: 3 SLIGHTLY REDDENED AREAS THE SIZE OF THE ELECTRODE WERE NOTED AND THE FOURTH ELECTRODE LEAD AREA WAS BLISTERED. THE BLISTER WAS THE SIZE OF A DIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention YES - 3M RED DOT ELECTRODES #2255-3