BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T 15CH SENSE SPINE COIL

    MDR report key: 2783582 · Received October 4, 2012

    Report

    Report Number
    1056069-2012-00006
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    April 27, 2012
    Report Date
    May 28, 2012
    Manufacturer
    INVIVO CORP.
    Product Code
    MOS
    PMA / PMN Number
    K062767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A F/U TO MEDWATCH # 3003768277-2012-00046 REPORTED TO FDA BY PHILIPS MEDICAL SYSTEMS ON (B)(6) 2012. IN THIS ORIGINAL REPORT PHILIPS IDENTIFIED TWO DEVICES INVOLVED IN THE ADVERSE EVENT, AN MRI SCANNER (MANUFACTURED BY BEST, A PHILIPS COMPANY) AND AN MRI COIL ACCESSORY DEVICE (MANUFACTURED BY INVIVO CORP., A PHILIPS COMPANY). DUE TO AN ADMINISTRATION OVERSIGHT, A SEPARATE MEDWATCH REPORT WAS NOT SUBMITTED UNDER INVIVO'S ESTABLISHMENT REGISTRATION NUMBER. THE PURPOSE OF THIS REPORT IS TO CORRECT THIS ERROR BY PROVIDING A FINAL MEDWATCH REPORT FOR THE MR COIL ACCESSORY DEVICE UNDER INVIVO'S ESTABLISHMENT REGISTRATION NUMBER #(B)(4). (B)(4). (RESULTS) - ELECTRICAL TESTS PERFORMED, PERFORMANCE TEST OF ALL SPECIFICATION PERFORMED, VISUAL INSPECTION. DEVICE PASSED ALL VISUAL INSPECTION (NO SIGNS OF OVERHEATING), PASSED ALL BENCH AND SYSTEM TESTS. NO DEVICE FAILURE. THE SYMPTOM DESCRIBED IN THIS EVENT COULD NOT BE REPRODUCED. THERE WERE NO SIGNS OF THE DEVICE HEATING UP ENOUGH TO CAUSE BURNS ON THE BACK OF THE HAND. ALL TESTS CONFIRM THAT THE DEVICE PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A MALE PT WAS POSITIONED HEAD FIRST, SUPINE AND EXAMINED WITH THE SENSE SPINE COIL. AFTER THE EXAMINATION A SECOND DEGREE BURN OF 3CM X 3CM ON THE HAND AND A SECOND DEGREE BURN ON THE THIGH WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5T 15CH SENSE SPINE COIL MOS INVIVO CORP. 4522-132-64363

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other