BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY PACS

    MDR report key: 1353609 · Received February 12, 2009

    Report

    Report Number
    3004526608-2009-00011
    Event Type
    Malfunction
    Date Received
    February 12, 2009
    Date of Event
    November 10, 2008
    Report Date
    November 10, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    PMA / PMN Number
    K043415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT. A FOLLOW-UP REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    SEVERAL REPORTS WERE FOUND IN THE WEB THAT DO NOT CORRESPOND TO THE CORRECT REPORTS DONE IN RIS. THE REPORTS IN WEB CAN BE VIEWED BY THE PHYSICIAN BUT HE/SHE MAY BE READING A REPORT FROM ANOTHER PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY PACS PACS SERVER LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS S/W VERSIONS2.1.2.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1