BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY

    MDR report key: 2170242 · Received July 19, 2011

    Report

    Report Number
    2170242
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    April 10, 2009
    Report Date
    July 19, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD MAMMOGRAM IN SPRING OF 2011. UPON REVIEW OF PRIOR IMAGES IT WAS NOTICED THAT THREE OF THE FOUR IMAGES FROM 3 YEARS PREVIOUSLY DID NOT SAVE CORRECTLY IN OUR PACS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY PACS SYSTEM LLZ GE MEDICAL SYSTEMS, LLC. CENTRICITY RIS-IC 10.3.9 PACS VERSION 3.3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR