BEUDAMED
    FDA Adverse Event Summary report: N

    CENTRICITY PACS RA1000

    MDR report key: 1329087 · Received February 5, 2009

    Report

    Report Number
    3004526608-2009-00004
    Date Received
    February 5, 2009
    Report Date
    April 20, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    PMA / PMN Number
    K023557
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED LATE AS THIS IS PART OF OUR ONGOING QUALITY IMPROVEMENT ACTIVITIES. WE HAVE UPDATED THE RISK ASSESSMENT CONTROL RECORD AND THE UPDATE HAS RESULTED IN THE ASSESSMENT THAT THESE REPORTED COMPLAINTS MEET THE REPORTABILITY CRITERIA AS OUTLINED IN THE RISK ASSESSMENT CONTROL RECORD FOR GE HEALTHCARE. EVENT IS NOT REPRODUCIBLE AND/OR CANNOT BE REPLICATED UNDER THE SPECIFIED OPERATING CONDITIONS OF THE DEVICE. THE FLIPPED IMAGES HAD THE CORRECT IMAGE ORIENTATION MARKERS PRESENT ON THE IMAGES, WHICH ARE REQUIRED DICOM VALUES FOR ALL CT SCANNERS. IT WOULD BE OBVIOUS TO THE RADIOLOGIST THAT THE IMAGES WERE FLIPPED WHEN THE STUDY WAS OPENED FOR DICTATION. THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    WHEN THE RADIOLOGIST OPENS UP THE STUDY, SOME OF THE IMAGES ARE FLIPPED. ISSUE IS INTERMITTENT AND ONLY HAPPENS AFTER THE EXAM HAS BEEN VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY PACS RA1000 RA1000 LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS 2.1.2.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1