BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI-TRAK 3100 MONITOR

    MDR report key: 97005 · Received June 9, 1997

    Report

    Report Number
    1051786-1997-00005
    Event Type
    Injury
    Date Received
    June 9, 1997
    Date of Event
    April 1, 1997
    Report Date
    June 6, 1997
    Manufacturer
    INVIVO RESEARCH, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SERIES OF MRI LUMBAR SPINE SCANS WHICH LASTED APPROX 60 MINUTES, A PT WHO WAS UNDER ANESTHESIA RECEIVED 4 SEVERE BURNS (EACH APPROXIMATELY THE SIZE OF A 25 CENT COIN) BENEATH THE ECG ELECTRODES USED DURING THE SCANS. DURING THESE SCANS AN MRI PHASED-ARRAY SURFACE COIL WAS USED WITH THE PT. THE PT UNDERWENT SEVERAL HIGHER POWER SCANS, BUT SPECIFIC INFO ABOUT THE SCANS IS NOT KNOWN AT THIS TIME. THE HOSPITAL RISK MGMT HAS LIMITED THE INFO WHICH IS AVAILABLE. NO SPECIFIC PT INFO IS YET AVAILABLE, BUT A VISIT TO THIS HOSPITAL IS SCHEDULED FOR JUNE 12 FOR OBTAINING FURTHER INFO.

    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 GENERAL ELECTRIC 1.5 TESLA MRI SYSTEM