BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-TRAK 3100 MONITOR

    MDR report key: 44811 · Received October 18, 1996

    Report

    Report Number
    1051786-1996-00003
    Event Type
    Malfunction
    Date Received
    October 18, 1996
    Date of Event
    September 10, 1996
    Report Date
    October 17, 1996
    Manufacturer
    INVIVO RESEARCH, INC.
    Product Code
    DRT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN MRI PROCEDURE, AN ANESTHESIZED PT WAS BEING MONITORED WITH AN ECG MONITOR. FOLLOWING THE PROCEDURE, PT WAS RELEASED WITH NO EVIDENCE OF SKIN BURNS. ONE WEEK LATER (ON 9/17/96) THE PT RETURNED FOR ANOTHER MRI SCAN, AND EVIDENCE OF 2 SKIN BLISTERS WAS OBSERVED WHERE THE RA AND LA ECG ELECTRODES WERE POSITIONED DURING THE MRI SCAN 1 WEEK EARLIER. BOTH BLISTERS WERE APPROX "DIME-SIZED" AND HEALING. PT DID NOT REPORT ANY SENSATION OF SKIN DISCOMFORT UPON RECOVERY FROM ANESTHESIA. ECG ELECTRODE CONTACT IS SUSPECT SINCE ELECTRODES DID NOT HAVE SUFFICIENT ELECTROLYTE EVIDENT.

    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 47 YR 3M RED DOT TYPE 2246 ECG ELECTRODES| GE 1.5T MRI