BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON OVAL

    MDR report key: 4120806 · Received September 26, 2014

    Report

    Report Number
    8030405-2014-00009
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    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
    OH, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, WE DISPATCHED SERVICE TO DIAGNOSE AND REPAIR THE ECHELON OVAL MRI SYSTEM. THEY CONFIRMED THAT ONE OF THE CHANNELS ON THE GRADIENT COIL HAD AN OPEN CIRCUIT. THE GRADIENT COIL SHOWED NO EXTERNAL SIGNS OF OVERHEATING. DURING TROUBLESHOOTING, THERE WAS NO EVIDENCE THAT THE FAILED COIL HAD CAUSED A HEALTH RISK THAT WAS REPORTABLE AS A MDR. THE DEFECTIVE COIL WAS RETURNED TO HITACHI IN (B)(6) FOR AN IN-DEPTH ENGINEERING ANALYSIS. ON (B)(6) 2014, WE RECEIVED NEW INFORMATION ON THE FAILURE. THE ANALYSIS REVEALED THAT A FLEXIBLE (BRAIDED) CONDUCTOR OF THE Y CHANNEL WAS BROKEN. THE ROOT CAUSE WAS DETERMINED TO BE VIBRATION FATIGUE. THE CABLE CONNECTION WAS TRACED TO THE SAME ROOT CAUSE AS THE EVENT REPORTED UNDER MDR (B)(6). IN THE PREVIOUS CASE, THE CONNECTION ARCED WHEN IT FAILED, SO THERE WAS EXTERNAL DAMAGE TO THE EPOXY INSULATION SURROUNDING THE BRAIDED CABLE. IN THIS CASE, THERE WAS NO SUCH EXTERNAL DAMAGE, BUT HITACHI CHOSE TO REPORT THIS AS A MDR SINCE THE ROOT CAUSE WAS THE SAME. (B)(6) INITIATED A CORRECTIVE ACTION BASED ON THE FAILURE REPORTED UNDER MDR 8030405-2014-00002, SYSTEM Y001 WAS INCLUDED IN THE LIST OF AFFECTED SYSTEMS AND HAS BEEN CORRECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, DURING SCANNING THE HITACHI ECHELON OVAL SYSTEM MADE A LOUD NOISE. WHEN THE TECHNOLOGIST WENT IN TO THE SCAN ROOM IT SMELLED LIKE SOMETHING WAS BURNING. THE SYSTEM REPORTED A GRADIENT AMPLIFIER ERROR. THE PATIENT WAS UNHARMED AND WAS RELEASED. THE EXAM WAS INCOMPLETE. HITACHI SERVICE DETERMINED THAT THE GRADIENT COIL FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601588 ECHELON OVAL MAGNETIC RESONANCE IMAGING DEVICE LNH HITACHI MEDICAL CORPORATION ECHELON OVAL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1