BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACS-IC

    MDR report key: 1279868 · Received December 24, 2008

    Report

    Report Number
    3004526608-2008-00095
    Event Type
    Malfunction
    Date Received
    December 24, 2008
    Date of Event
    November 26, 2008
    Report Date
    December 18, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THIS ISSUE. THE SOFTWARE FOR THIS SYSTEM IS PRODUCED BY ANOTHER COMPANY AND RESOLD WITH THIS PRODUCT. IT WAS DISCOVERED THAT COMPANY HAS A SOFTWARE PATCH AVAILABLE TO CORRECT THIS ISSUE AND THIS PARTICULAR FACILITY HAS NOT HAD THE SOFTWARE PATCH INSTALLED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE ISSUE WAS REFERRED TO THE OTHER COMPANY TO HAVE THE SOFTWARE PATCH INSTALLED AT THIS FACILITY TO CORRECT THE ISSUE REPORTED.

    Description of Event or Problem · 1

    MAMMOGRAPHY IMAGES WERE STORED/DISPLAYED INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACS-IC RA1000 LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS RA1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1