BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON OVAL

    MDR report key: 4746337 · Received May 4, 2015

    Report

    Report Number
    8030405-2015-00006
    Event Type
    Malfunction
    Date Received
    May 4, 2015
    Date of Event
    March 10, 2015
    Report Date
    March 10, 2015
    Manufacturer
    HITACHI MEDICAL CORPORATION
    Product Code
    LNH
    PMA / PMN Number
    K113145
    Removal / Correction Number
    1528028-07/02/14-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 03/11/2015, HITACHI DISPATCHED SERVICE ENGINEERS TO INVESTIGATE THE FAILED GRADIENT COIL. THEY CONFIRMED THAT ONE OF THE INTERNAL FLEXIBLE CONDUCTORS (Y CHANNEL CABLE) CONNECTING TO THE REAR OF THE GRADIENT COIL ASSEMBLY WAS OPEN. DURING THE INSPECTION, THERE WAS NO EVIDENCE THAT THE FAILED COIL HAD CAUSED AN HEALTH RISK THAT WAS REPORTABLE AS A MDR. THE DEFECTIVE COIL WAS RETURNED TO HITACHI IN (B)(4) FOR AN IN-DEPTH ENGINEERING ANALYSIS. ON APRIL 17, 2015, WE RECEIVED NEW INFORMATION ON THE FAILURE. THE ANALYSIS REVEALED THAT THE ROOT CAUSE OF THE OPEN Y CHANNEL CONDUCTOR WAS VIBRATION FATIGUE. THE CABLE CONNECTION WAS TRACED TO THE SAME ROOT CAUSE AS THE EVENT REPORTED UNDER MDR 8030405-2014-00002. IN THE PREVIOUS CASE, THE CONNECTION ARCED WHEN IT FAILED, SO THERE WAS EXTERNAL DAMAGE TO THE EPOXY. HITACHI WAS AWARE OF THE POTENTIAL FOR THIS FAILURE AND IS CONDUCTING A CLASS II RECALL ACTION UNDER FDA NUMBER Z-2564-2014 IN THE USA. IN EUROPE, 2 SYSTEMS WERE AFFECTED. THE Y501 SYSTEM WAS THE SECOND UNIT AND WAS SCHEDULED FOR A GRADIENT COIL REPLACEMENT AT THE TIME OF THE FAILURE. THE RECALL ACTION IN THE USA HAS CORRECTED ABOUT 85% OF THE INSTALLED BASE TO DATE. FAILURE ANALYSIS PREDICTED A FAILURE RISK FOR COILS WITH >50K SCANS. ALL >50K UNITS IN THE USA HAVE BEEN CORRECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, DURING SCANNING THE HITACHI ECHELON OVAL SYSTEM STOPPED OPERATING. THE SITE REPORTED AN LOUD NOISE FOLLOWED BY A BURNING SMELL. THE SYSTEM REPORTED A GRADIENT AMPLIFIER ERROR. THE PATIENT WAS UNHARMED AND WAS RELEASED. HITACHI SERVICE DETERMINED THAT ONE OF THE CONNECTIONS TO THE GRADIENT COIL FAILED OPEN BUT THERE WAS NO VISUAL INDICATION OF COMPONENT OVERHEATING AT THE TIME OF THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291244 ECHELON OVAL MAGNETIC RESONANCE IMAGING DEVICE LNH HITACHI MEDICAL CORPORATION ECHELON OVAL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR