BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRICITY RA1000

    MDR report key: 1085369 · Received July 31, 2008

    Report

    Report Number
    3004526608-2008-00018
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    June 8, 2007
    Report Date
    June 8, 2007
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED LATE, AS THIS ISSUE WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINT FILES. THIS ACTIVITY IS BEING COMPLETED AS PART OF A CORRECTIVE ACTION TAKEN PURSUANT TO AN FDA INSPECTION CONDUCTED AT THE FACILITY IN APRIL 2008. NON-SUPPORTED SPECIAL CHARACTERS WERE USED IN DDP NAMES. UPON INVESTIGATION, IT WAS DISCOVERED THAT THE CUSTOMER HAD USED SPECIAL CHARACTERS IN THE DESCRIPTIONS AND DDP NAMES, WHICH IS NOT SUPPORTED IN PACS. THIS ISSUE CAN CAUSE USER CREATED DDPS TO FAIL AND THEN REVERT BACK TO GE DDP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A USER IS VIEWING AN EXAMINATION OF 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 LEFT MONITOR. IT WAS REPORTED THAT AS A RESULT OF THIS SITUATION, A PATIENT UNDERWENT UNNECESSARY SURGERY.

    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 Hospitalization| R