BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY PACS

    MDR report key: 1277485 · Received December 18, 2008

    Report

    Report Number
    3004526608-2008-00103
    Event Type
    Malfunction
    Date Received
    December 18, 2008
    Date of Event
    November 25, 2008
    Report Date
    December 18, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE ISSUE WITH THE CUSTOMERS SYSTEM. THE DEFAULT DISPLAY PROTOCOLS WERE RELOADED TO THE USERS ACCOUNT. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. THIS SYSTEM IS BEING MONITORED AND REMAINS IN USE AT THE FACILITY.

    Description of Event or Problem · 1

    CORRUPT DEFAULT DISPLAY PROTOCOL. CUSTOMER REPORTED THAT "HANGING" PROTOCOLS WERE CORRUPT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1