BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KDS COMPUTED RADIOGRAPHY SYSTEM 400

    MDR report key: 101866 · Received June 27, 1997

    Report

    Report Number
    1643366-1997-00001
    Event Type
    Malfunction
    Date Received
    June 27, 1997
    Date of Event
    June 1, 1997
    Report Date
    June 26, 1997
    Manufacturer
    KODAK HEALTH IMAGING DIV.
    Product Code
    LMD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    IMAGE TRANSFER FROM THE KODAK EKTASCAN STORAGE PHOSPOR READER (KESPER) TO THE QUALITY CONTROL WORKSTATION (QCW) WAS NOT POSSIBLE DUE TO POTENTIAL DATABASE CORRUPTION INITIATED BY IMPROPER SHUTDOWN OF BOTH SYSTEMS BY HOSPITAL PERSONNEL. THE CR-400 SYSTEM (COMPUTED RADIOGRAPHY) MET ITS PERFORMANCE SPECIFICATIONS IN ACCORDANCE WITH ITS LABELING. THE MALFUNCTION WAS ATTRIBUTED TO USER ERROR. THE SYSTEMS WERE REBOOTED WITHOUT FOLLOWING THE APPROPRIATE RECOVERY INSTRUCTIONS. THE PT EXPIRED PRIOR TO THE SCANNING AND TRANSFER OF THE IMAGE ACCORDING TO HOSPITAL PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KDS COMPUTED RADIOGRAPHY SYSTEM 400 COMPUTED RADIOGRAPHY LMD KODAK HEALTH IMAGING DIV. CR MODEL 400 03669150, 3619138 K'S

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR