BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FCR GO

    MDR report key: 2263749 · Received September 15, 2011

    Report

    Report Number
    2263749
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    June 18, 2011
    Report Date
    September 14, 2011
    Manufacturer
    FUJIFILM MEDICAL SYSTEMS USA, INC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER RADIOLOGY TECH TOOK PORTABLE X-RAY OF PATIENT, SHE GOT AN ERROR MESSAGE STATING THAT THE SYSTEM COULD NOT SEND THE IMAGE. SHE ATTEMPTED TO REBOOT THE MACHINE WHICH TOOK APPROXIMATELY ONE HOUR. AFTER REBOOT, TECH STILL COULD NOT GET IMAGE TO INTERFACE WITH PICTURE ARCHIVES AND COMMUNICATIONS SYSTEM (PACS). 2ND X-RAY OF PATIENT HAD TO BE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FCR GO X-RAY SYSTEM, PORTABLE IZL FUJIFILM MEDICAL SYSTEMS USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR