BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY RA1000

    MDR report key: 1160639 · Received September 1, 2008

    Report

    Report Number
    3004526608-2008-00067
    Event Type
    Malfunction
    Date Received
    September 1, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 18, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ACTIVITY IS BEING COMPLETED AS PART OF CORRECTIVE ACTION. AN INVESTIGATION IS BEING CONDUCTED TO DETERMINE ROOT CAUSE. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A USER IS VIEWING AN EXAMINATION ON A PACS (PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM) WORKSTATION, THE USER'S PERSONAL DDP (DEFAULT DISPLAY PROTOCOL-AN AUTOMATIC WAY THE IMAGES ARE DISPLAYED WHEN THE EXAM OPENS), AND THE CUSTOMER (SITE) DDP FAILS TO AUTO DISPLAY, THE SYSTEM REVERTS BACK TO GE DDP WITHOUT NOTICE. THE USER MAY NOT REALIZE THE EXAM ORDER HAS CHANGED, CAUSING THEM TO BELIEVE THAT THE OLD EXAM IS THE NEW ONE AND VICE VERSA. THIS COULD CAUSE THE RADIOLOGIST TO BELIEVE PATIENT PATHOLOGY HAS GOTTEN BETTER OR WORSE THAN IS TRUE, IF THEY DO NOT REVIEW THE DATE STAMP IN THE TITLE BAR. THE GE DDP IS SET TO DISPLAY THE CURRENT EXAM ON THE RIGHT MONITOR AND THE PREVIOUS OR HISTORICAL EXAM ON THE LET MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK