BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-TRAK 3100 MONITOR

    MDR report key: 57480 · Received December 18, 1996

    Report

    Report Number
    1051786-1996-00007
    Event Type
    Malfunction
    Date Received
    December 18, 1996
    Date of Event
    November 12, 1996
    Report Date
    December 17, 1996
    Manufacturer
    INVIVO RESEARCH INC.
    Product Code
    DRT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN MRI PROCEDURE, AN ANESTHETIZED FEMALE PT WAS BEING MONITORED WITH AN ECG MONITOR. FOLLOWING THE PROCEDURE A 3/4 INCH SKIN BLISTER WAS OBSERVED BENEATH THE RA ELECTRODE. THE BLISTER WAS TREATED WITH CORTISONE CREAM. PT WAS UNDER GENERAL ANESTHESIA DURING THE MRI PROCEDURE. PT'S SKIN WAS TOUCHING THE MRI BORE DURING PORTIONS OF THE MRI SCANS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention 3M RED DOT, TYPE 2246 ECC-ELECTRODES| GE 1ST MRI