BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 2080652 · Received April 26, 2011

    Report

    Report Number
    8030405-2011-00003
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    PMA / PMN Number
    K052172
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ECHELON IS A 1.5 TESLA MAGNET. THE PT WAS SCANNED WITH THE TRANSMIT/RECEIVE COIL UNDER THE COVER OF THE MAGNET BORE, SO ON (B)(6) 2011 HEAT TESTS WERE DONE ON THOSE SURFACES. THE MAXIMUM SURFACE TEMPERATURE READING WAS 82 DEGREES F. TRANSMITTER CALIBRATION WAS CHECKED AND WAS WITHIN SPECS. THE IMAGES OF THE PT WERE REVIEWED. NO IMAGE QUALITY PROBLEMS WERE NOTED. THERE WAS NO INDICATION OF A SYSTEM MALFUNCTION. THE REVIEWER DID NOTE THAT THE PT'S THIGHS APPEAR TO BE TOUCHING IN THE FIRST SERIES OF IMAGES. THE SITE INDICATED THAT THERE WAS ONLY A SHEET SEPARATING THE PT'S LEGS DURING THE FIRST PORTION OF THE EXAM. THE SITE REPORTED THEY HAD CONTACT WITH THE PT ON (B)(6) 2011. THE PT'S BURNS WERE SCABBED OVER AND HEALING. THE PT DID NOT RECEIVE ANY FORMAL TREATMENT BUT DID APPLY THE (B)(6) ANTIBIOTIC OINTMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A PT WAS SCANNED ON THE HITACHI ECHELON MRI SYSTEM. THE PT'S UPPER THIGH WAS SCANNED, AND WHEN THE TECHNOLOGIST WAS REPOSITIONING THE PT TO SCAN THE LOWER THIGH, THE PT COMPLAINED OF FEELING VERY WARM BETWEEN HIS THIGHS. A BLANKET WAS PLACED BETWEEN THE PT'S THIGHS AND THE SCAN WAS CONTINUED. AFTER THE EXAM, THE TECHNOLOGIST NOTICED A 1 CM DIAMETER BURN ON THE UPPER PART OF BOTH THIGHS. THE PT'S DR WAS CALLED BY THE SITE AFTER THE INJURY WAS NOTICED AND HE DIRECTED THE PT TO PUT AN (B)(6) TRIPLE ANTIBIOTIC OINTMENT ON THE BURNS. THE SITE NOTIFIED THE PT OF THE ADVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH HITACHI MEDICAL CORP. ECHELON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other