BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-TRAK 3100 MONITOR

    MDR report key: 107438 · Received July 17, 1997

    Report

    Report Number
    1051786-1997-00006
    Event Type
    Malfunction
    Date Received
    July 17, 1997
    Date of Event
    June 12, 1997
    Report Date
    July 13, 1997
    Manufacturer
    INVIVO RESEARCH, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A SERIES OF MRI CHEST SCANS OF AN ADULT MALE PATIENT WHICH LASTED APPROXIMATELY 40 MINUTES, 3 SKIN BLISTERS WERE OBSERVED ON THE PATIENT'S BACK WHERE THE ECG ELECTRODES WERE PLACED. THE PT WAS CONSCIOUS DURING THE SCANS, BUT DID NOT REPORT ANY HEATING SENSATION.. AT THE END OF THE SCANS, THE PT REPORTED FEELING DISCOMFORT ON HIS BACK, AND THE SKIN IN THE AREA OF THE ELECTRODES WAS REDDENED. THE PT WAS POSITIONED IN THE MRI BORE FEET FIRST, WITH THE PT CABLE EXITING THE CENTER OF THE MRI BORE ALONG SIDE THE PT'S HEAD. THE PT'S SKIN BLISTERS WERE CONSIDERED MINOR, AND TREATED WITH SILVADENE SKIN CREAM. THE PT WAS REFERRED TO HIS FAMILY PHYSICIAN FOR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI-TRAK 3100 MONITOR PATIENT VITAL SIGNS MONITOR DRT INVIVO RESEARCH, INC. 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention G.E. MEDICAL SIGNA 1.5 TELSA MIR SYSTEM, 3M RED| DOT TYPE 2246 ECG ELECTRODES