BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM FDR GO

    MDR report key: 4945172 · Received July 24, 2015

    Report

    Report Number
    8030233-2015-00001
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    May 17, 2015
    Report Date
    July 23, 2015
    Manufacturer
    SHIMADZU CORP.
    Product Code
    IZL
    PMA / PMN Number
    K080701
    Product Problem
    Yes
    Report Source
    Manufacturer 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 FOR FUJIFILM AND LABELED AS A "FUJIFILM FDR GO". THE FDR GO'S CONSOLE (OR WORKSTATION) USES ACQUISITION WORKSTATION SOFTWARE DEVELOPED BY FUJIFILM. (B)(4) IMPORTS THE FDR GO INTO THE UNITED STATES. INVESTIGATION BY IMPORTER HAS DETERMINED THAT A VERY SPECIFIC (AND ALSO UNEXPECTED) SEQUENCE OF STEPS PERFORMED WHEN ADDING ANNOTATIONS TO THE IMAGE CAUSED THE ISSUE. THE ISSUE PREVENTED THE SYSTEM FROM TRANSFERRING THE IMAGE TO PACS. TESTING ALSO SHOWED THAT THE IMAGE WAS STILL RESIDENT ON THE DR-ID800 AND THAT IT COULD HAVE BEEN RESENT TO PACS IF THE ANNOTATIONS HAD BEEN REMOVED. ORIGINAL CHEST X-RAY IMAGE DATA WAS REMAINED IN THE PRODUCT. ANOTHER CHEST X-RAY SHOULD NOT HAVE BEEN NEEDED. IF NECESSARY ADDITIONAL REMEDIAL ACTION, IT WILL BE INCLUDING IN FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE EVENT DESCRIPTION AS RECEIVED IN THE USER FACILITY REPORT ((B)(4)) WAS: "EVENT DESC: PORTABLE OF PATIENT. 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 INFORMATION REGARDING THE ALLEGED EVENT: TYPICALLY PORTABLE EXAMS ARE TAKEN (IN PATIENT 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 INFORMATION 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
    482664 FUJIFILM FDR GO MOBILE X-RAY SYSTEM IZL SHIMADZU CORP. FDR GO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other