BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECHELON

    MDR report key: 2625768 · Received June 13, 2012

    Report

    Report Number
    8030405-2012-00005
    Event Type
    Other
    Date Received
    June 13, 2012
    Date of Event
    May 15, 2012
    Report Date
    May 15, 2012
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    PMA / PMN Number
    K083533
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ECHELON IS A 1.5 TESLA CLOSED BORE MAGNET. HITACHI DETERMINED DURING THE INVESTIGATION THAT THE PT CALL SWITCH UNIT CABLE WAS LAID ACROSS THE PT'S LEGS IN THE VICINITY OF THE BLISTER LOCATION. A BLANKET WAS PLACED OVER THE CABLE AND THE RECEIVE COIL PLACED OVER BOTH. NORMAL PRACTICE IS TO PLACE THE CALL SWITCH CABLE AWAY FROM THE BODY AND NOT UNDER THE RECEIVE COIL. THE CABLE IS INSULATED, BUT ADDITIONAL COVERS ARE PROVIDED IF NEEDED TO PREVENT BODY CONTACT. HITACHI SERVICE TESTED THE TORSO COIL FOR HEATING DEFECTS. TESTS NEGATIVE FOR TEMPS >41 DEG C (IEC STANDARD). ROOM TEMPERATURE WAS BETWEEN 22 AND 24 DEGREES CELSIUS. CLINICAL SCIENCE REVIEWED IMAGES FOR ISSUES. NO PROTOCOL PROBLEMS NOTED, SAR LEVELS UNDER 2.0 W/KG. IMAGE QUALITY WAS SUB-OPTIMAL. POSITIONING ISSUES CONTRIBUTED TO LOWER IMAGE QUALITY. IMAGES WERE DIAGNOSTIC. COIL WAS REPLACED TO TEST FURTHER. BENCH TESTS CONFIRMED ALL ELEMENTS AND DECOUPLERS FUNCTIONAL. SIGNAL TO NOISE TESTS WERE WITHIN SPECIFICATION. A SLIGHT DEFORMITY WAS DETECTED IN A CIRCUIT COVER OPPOSITE THE PT SURFACE. HEAT TESTING OF UNCOVERED CIRCUIT SHOWED MAX TEMP AT 46 DEGREES CELSIUS, AND WAS THE PROBABLE CAUSE OF COVER DEFORMING OVER TIME. PT SURFACE OPPOSITE THIS AREA MAX 30 DEGREES CELSIUS. FURTHER TESTING OF THE COIL SHOWED DECOUPLER CIRCUITS MISTUNED TO THE INCORRECT FREQUENCY, WHICH WOULD LESSEN EFFICIENCY AND RAISE AMBIENT HEAT. ERROR OCCURRED IN MANUFACTURING. COIL USED ROUTINELY AT SITE SINCE AUGUST 2010 WITH NO PREVIOUS THERMAL COMPLAINTS. HITACHI BELIEVES THAT THE COMBINATION OF THE CALL SWITCH CABLE POSITION, BLANKET (AS INSULATOR) AND DE-TUNED TORSO COIL IS THE PROBABLE ROOT CAUSE OF THE INCIDENT. HOWEVER, A TEST TO DUPLICATE THE SETUP DID NOT DETECT ANY LOCAL HEATING. SITE OPERATORS RE-TRAINED ON POSITIONING COILS, CABLES. NO FURTHER PROBLEMS REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PT WAS BEING SCANNED ON THE HITACHI ECHELON SYSTEM FOR LOWER EXTREMITY EXAM. THE PT WAS COMPLAINING OF A BURNING SENSATION TO THE RLE BEFORE THE EXAM BEGAN. PT WAS POSITIONED FOR A PROXIMAL FEMUR EXAM (RIGHT) USING A TORSO RECEIVE COIL DUE TO PT SIZE. THE PT HAD NO COMPLAINTS DURING THIS EXAM. AFTERWARDS, THE PT WAS REPOSITIONED FOR A LOWER RIGHT LEG SCAN AND GIVEN PAIN MEDICATION. THE SECOND PART OF THE EXAM USED AN EXTREMITY RECEIVE COIL. NEAR THE END OF THE EXAM THE PT AGAIN COMPLAINED OF A BURNING SENSATION OF THE RLE. THE EXAM WAS COMPLETED AFTER THE TECHNOLOGIST PAUSED TO GIVE THE PT A BREAK. AFTERWARDS, THE PT WAS TRANSFERRED BACK TO THE ICU AND DID NOT COMPLAIN FURTHER. APPROXIMATELY 30 MINUTES AFTER THE EXAM WAS COMPLETED, THE RN CALLED TO REPORT BLISTERS ON THE PT'S LEFT LEG JUST ABOVE THE KNEE. WOUND CARE WAS GIVEN WHILE IN IN-PATIENT. THE PT WAS POSITIONED FEET FIRST, SUPINE. DURING THE EXAM THE TORSO COIL WAS SURROUNDING THE BLISTERED AREA.

    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 40 YR Required Intervention