BEUDAMED
    FDA Adverse Event Other Summary report: N

    CENTRICITY WEB

    MDR report key: 1200195 · Received September 26, 2008

    Report

    Report Number
    9681779-2008-00002
    Event Type
    Other
    Date Received
    September 26, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 27, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CENTRICITY WEB EXPERIENCED A FORCED LOG OUT MIDWAY THROUGH A SURGICAL PROCEDURE WHERE THE SURGEON WAS RELYING ON THE CWEB IMAGES TO BE ABLE TO PROCEED WITH THE PROCEDURE. THE APPROXIMATE TIME OF THE DELAY WAS REPORTED TO BE 8 MINUTES. THE FORCED LOG OUT OCCURRED DUE TO A BUG CREATING THE CWEB FORCE OUT, RATHER THAN CWEB SESSION ENDING AT A PRESET TIME. CENTRICITY WEB IS INTENDED FOR IMAGE REVIEW AND NOT FOR DIAGNOSTIC USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other