BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI-TRAK 3100 MONITOR

    MDR report key: 87150 · Received April 24, 1997

    Report

    Report Number
    1051786-1997-00003
    Event Type
    Injury
    Date Received
    April 24, 1997
    Date of Event
    March 25, 1997
    Report Date
    April 24, 1997
    Manufacturer
    INVIVO RESEARCH, INC.
    Product Code
    DRT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN MRI PROCEDURE, A LARGE MALE PATIENT WAS BEING MONITORED WITH AN ECG MONITOR. AFTER APPROXIMATELY 20 MINUTES OF SCANNING, THE PATIENT WAS REMOVED FROM THE MRI AND 3 OF THE 4 ECG ELECTRODE SKIN SITES HAD SKIN BLISTERS FORM BENEATH THE ELECTRODES. SKIN REDDENING WAS ALSO NOTED ON THE PATIENT'S CHEST WHERE THE ECG WAS PRESSED AGAINST THE SKIN BY THE PATIENT'S SHIFT. THE PATIENT RECEIVED CONSCIOUS SEDATION DURING THE SCANS, AND WAS CONSCIOUS DURING THE SCANS, BUT DID NOT REPORT FEELING ANY HEATING SENSATION. THE SKIN BURNS WERE TREATED BY THE HOSPITAL STAFF, AND THE PATIENT WAS DISCHARGED FOLLOWING TREATMENT.

    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 ELECTRO-TRACE SOLID-GEL ECG ELECTRODES| TRACE SOLID-GEL ECG ELECTRODES| GENRERAL ELECTRIC 1.5 TESLA MRI SYSTEM