BEUDAMED
    FDA Adverse Event Other Summary report: N

    INGENUITY CORE128

    MDR report key: 3828936 · Received May 7, 2014

    Report

    Report Number
    1525965-2014-00099
    Event Type
    Other
    Date Received
    May 7, 2014
    Report Date
    April 8, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER SCANNING TWO PTS THE SYSTEM CREATED PT FOLDERS FOR THE TWO PTS AND ALSO A THIRD PT FOLDER. THE THIRD PT FOLDER CONTAINED THE IMAGES FROM THE FIRS TPT WITH THE INFO FOR THE SECOND PT. THESE RESULTS WERE EXPORTED TO PACS SYSTEM. THE CUSTOMER CONTACTED THE LOCAL HELP DESK AND WAS ABLE TO SUCCESSFULLY PERFORM AN OFFLINE RECONSTRUCTION OF THE IMAGES FOR THE TWO PTS. THE CUSTOMER SUCCESSFULLY SEPARATED THE IMAGES ON THE PACS SYSTEM. A PHILIPS HELPDESK ENGINEER CONFIRMED THERE WAS NO MISINTERPRETATION, MISTREATMENT, OR RESCAN ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274968 INGENUITY CORE128 SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728323

    Patients

    Seq Age Sex Outcome Treatment
    1