BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM FDR GO

    MDR report key: 4937998 · Received July 22, 2015

    Report

    Report Number
    2443168-2015-00003
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    May 17, 2015
    Report Date
    July 22, 2015
    Manufacturer
    SHIMADZU CORPORATION
    Product Code
    IZL
    PMA / PMN Number
    K080701
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FDR GO IS A MOBILE X-RAY SYSTEM MANUFACTURED BY SHIMADZU CORPORATION FO FUJIFILM AND LABELED AS A "FUJIFILM FDS GO". THE FDR GO'S CONSOLE (OPERATING ROOM WORKSTATION) USES ACQUISITION WORKSTATION SOFTWARE DEVELOPED BY FUJIFILM. FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) IMPORTS THE FDR GO INTO THE UNITED STATES. FMSU IS COMPLETING AND SUBMITTING THIS MEDWATCH FORM AS THE IMPORTER. HOWEVER, WE HAVE ALSO INCLUDED INFO REGARDING (B)(4) AS THE MFR SO THAT ALL AVAILABLE RELEVANT INFO IS CONTAINED IN THIS ONE REPORT.

    Description of Event or Problem · 1

    THE EVENT DESCRIPTION AS RECEIVED IN THE USER FACILITY REPORT (B)(4) WAS: "EVENT DESC: PORTABLE UNIT WAS USED TO OBTAIN PORTABLE DIAGNOSTIC CHEST IMAGE OF PT. THE IMAGE COULD NOT BE TRANSFERRED TO IMAGE STORAGE SOFTWARE DUE TO A "GLITCH" IN THE SOFTWARE. THIS CAUSED THE TECHNICIAN TO TAKE A SECOND IMAGE. A SECOND SIMILAR EVENT OCCURRED SUBSEQUENTLY ON A SUBSEQUENT DATE AND WAS CORRECTED BY THE SOFTWARE VENDOR WITH A VERSION UPGRADE. APPEARED PROBLEM RELATED TO ANNOTATIONS MADE ON IMAGE BY THE TECHNICIAN CAUSED FILE CORRUPTION." THE USER REPORT CLASSIFIED THIS EVENT AS A DEVICE MALFUNCTION. FUJIFILM MEDICAL SYSTEMS PROVIDES THE FOLLOWING ADDITIONAL INFO REGARDING THE ALLEGED EVENT: TYPICALLY PORTABLE EXAMS ARE TAKEN (IN PT ROOMS, OPERATING ROOMS, ER, ETC.) AND TRANSFERRED THROUGH THE HOSPITAL NETWORK TO THE HOSPITAL'S PACS. IN THIS EVENT, THE CREATION OF IMAGE ANNOTATIONS APPARENTLY RESULTED IN THE IMAGE NOT BEING ABLE TO BE TRANSFERRED TO PACS. FURTHER INFO FROM THE USER FACILITY INDICATES THE TECHNOLOGIST PERFORMED THE EXAM AGAIN TO AVOID DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475180 FUJIFILM FDR GO MOBILE X-RAY SYSTEM IZL SHIMADZU CORPORATION FDR GO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other