BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY

    MDR report key: 2170200 · Received July 18, 2011

    Report

    Report Number
    2170200
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    November 9, 2010
    Report Date
    July 18, 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 A MAMMOGRAM IN LATE 2010. IMAGES WERE BEING REVIEWED PRIOR TO HER BREAST SURGERY 3 MONTHS LATER, AND IT WAS NOTICED THAT TWO OF THE IMAGES FROM HER 2010 STUDY 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 47 YR