BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR ACSELERATE DIGITAL STATIONARY X-RAY SYSTEM

    MDR report key: 2358425 · Received October 27, 2011

    Report

    Report Number
    2443168-2011-00002
    Event Type
    Malfunction
    Date Received
    October 27, 2011
    Date of Event
    July 18, 2011
    Report Date
    October 19, 2011
    Manufacturer
    FUJIFILM MEDICAL SYSTEM U.S.A., INC.
    Product Code
    MQB
    PMA / PMN Number
    K093427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE SOFTWARE WAS NOT RETURNED TO FUJI, THE ISSUE WAS REPLICATED AT FUJIFILM'S FACILITY IN (B)(4). CURRENTLY, THERE ARE (B)(4) ACSELERATE SYSTEMS INSTALLED IN (B)(4). OF THESE, ONLY (B)(4) ARE VERSION 3.4, WITH BOTH SITES REPORTING THEY DO NOT USE THE TOMOGRAPHY FUNCTION. THE REMAINING SITES ARE ON VERSION 2.2. A COMMUNICATION WAS SENT TO THE V3.4 SITES INFORMING THE SITES AT THIS VERSION OF THE ISSUE AND REQUESTING THAT THE SITES SUSPEND USING THE DEVICE IN THE TOMOGRAPHY MODE PENDING THE RELEASE OF A SOFTWARE RESOLUTION. FUJIFILM INTENDS TO INSTALL THE FIX TO ALL SITES VIA VERSION 3.7 WHICH WAS RELEASED TO (B)(4) ON (B)(4), 2011, VIA (B)(4).

    Description of Event or Problem · 1

    FUJIFILM MEDICAL SYSTEMS (B)(4) HAS BECOME AWARE FROM ITS AFFILIATE IN (B)(4) THAT WHEN THE TOMOGRAPHY FUNCTION IS SELECTED IN FUJIFILM'S DIGITAL RADIOGRAPHY ACSELERATE PRODUCT, THE POSSIBILITY EXISTS THAT THE EXPOSURE VALUES TO WHICH THE PATENT IS SUBJECTED MAY BE LARGER THAN WHAT IS INTENDED AND INDICATED ON THE X-RAY CONSOLE. IN THE CASE REPORTED, A PT UNDERGOING A TOMOGRAPHIC EXAM EXPERIENCED AN UNINTENDED EXPOSURE OF 1.6 MGY WHEREAS THE INTENDED DOSE WAS 0.12 MGY. AN INVESTIGATION PERFORMED BY FUJIFILM CORPORATION FOUND THAT THE SYSTEM DICOM DUMP DATA DID NOT CONTAIN THE REPORTED INTENDED EXPOSURE VALUE (120 UGYM2 RECORDED ON THE DAP) AT THE TIME THE INITIAL OBSERVATION WAS MADE BY THE RADIOGRAPHER. ALTHOUGH THE ACTUAL INTENDED VALUE OF THE INITIAL OBSERVATION WAS NOT RETRIEVABLE FROM THE DATA, IT HAS BEEN CONFIRMED THAT THE OVEREXPOSURE OCCURRED. FUJIFILM HAS DETERMINED THAT THE ISSUE IS ATTRIBUTABLE TO A SOFTWARE BUG IN VERSIONS 3.2 THROUGH 3.6 AND HAS ALREADY RELEASED A FIX FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FDR ACSELERATE DIGITAL STATIONARY X-RAY SYSTEM ACSELERATE MQB FUJIFILM MEDICAL SYSTEM U.S.A., INC. DR-IR 200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other