BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON OVAL

    MDR report key: 4248261 · Received November 13, 2014

    Report

    Report Number
    8030405-2014-00010
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 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
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, HITACHI DISPATCHED A FIELD SERVICE ENGINEER TO INVESTIGATE THE FAILED GRADIENT COIL. THEY CONFIRMED THAT ONE OF THE INTERNAL FLEXIBLE CONDUCTORS CONNECTING TO THE REAR OF THE GRADIENT COIL ASSEMBLY WAS BROKEN. THE CABLE CONNECTION IS CONTAINED IN A BLOCK OF RESIN USED TO INSULATE IT AND MINIMIZE MECHANICAL VIBRATION. BASED ON THE EVIDENCE, WE BELIEVE THAT THIS FLEXIBLE CONDUCTOR REACHED A HIGH TEMPERATURE AND ARCED JUST AFTER IT FAILED, AS A PORTION OF THE RESIN BLOCK AROUND THIS CONNECTION WAS PARTIALLY MELTED. THE CONNECTION POINT IS SEPARATED FROM THE PATIENT BY A COVER ASSEMBLY. THE INSIDE OF THE COVER ADJACENT TO THE GRADIENT COIL WAS SPECKLED WITH SOOT, BUT THERE WAS NO DAMAGE TO THE OUTSIDE OF THE COVER ADJACENT TO THE PATIENT SPACE. THIS FAILURE IS NEARLY IDENTICAL TO THE FAILURE REPORTED ON MDR 8030405-2014-00002. AFTER A FAILURE ANALYSIS OF THAT INCIDENT, HITACHI INITIATED A REPORTABLE CORRECTIVE ACTION UNDER THE NUMBER REFERENCED ABOVE. THE MANUFACTURER CHANGED THE FLEXIBLE CONNECTOR IN THE RESIN TO A SOLID COPPER CONNECTOR TO PREVENT REOCCURRENCE. (B)(4). THE FAILED GRADIENT COIL ON THIS SYSTEM WAS REPLACED BY THE IMPROVED VERSION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, DURING SCANNING THE HITACHI ECHELON OVAL MRI SYSTEM REPORTED A GRADIENT AMPLIFIER ERROR. WHEN THE TECHNOLOGIST WENT INT THE SCAN ROOM SHE DETECTED A FAINT BURNING SMELL. THERE WAS NO PATIENT INJURY. THE EXAM WAS INCOMPLETE. HITACHI SERVICE DETERMINED THAT ONE OF THE CONNECTIONS TO THE GRADIENT COIL OVERHEATED AND FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732121 ECHELON OVAL MAGNETIC RESONANCE IMAGING DEVICE LNH HITACHI MEDICAL CORPORATION ECHELON OVAL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1