BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNI-TRAK

    MDR report key: 610411 · Received June 1, 2005

    Report

    Report Number
    1051786-2005-00005
    Event Type
    Other
    Date Received
    June 1, 2005
    Report Date
    May 26, 2005
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DRT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON TWO OCCASIONS PATIENTS WERE REPORTEDLY BURNED DURING MRI SCANS. THE FIRST INCIDENT REPORTEDLY OCCURRED THE FOLLOWING MONTH INVOLVING A PT REPORTEDLY RECEIVED 3RD DEGREE BURNS ON THEIR STOMACH UNDER THE ELECTRODES DURING AN ABDOMEN SCAN. AFTER SEVERAL ATTEMPTS, THE MANUFACTURER WAS UNSUCCESSFUL IN OBTAINING ADDITIONAL INFORMATION FROM THE HOSPITAL REGARDING TREATMENT OR CURRENT CONDITION OF THE REPORTED PATIENT BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI-TRAK VITAL SIGNS MONITORING SYSTEM DRT INVIVO CORPORATION 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other