BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRICITY PACS SYSTEM

    MDR report key: 1296109 · Received January 27, 2009

    Report

    Report Number
    3004526608-2009-00002
    Event Type
    Injury
    Date Received
    January 27, 2009
    Date of Event
    January 13, 2009
    Report Date
    January 14, 2009
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    PMA / PMN Number
    K043415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITUATION WAS CAUSED BY AN INADEQUATE CONFIGURATION OF THE GE HEALTHCARE SYSTEM IN CONNECTION WITH A THIRD PARTY DEVICE. THE SETTING "REQUEST C-MOVE FROM PACS (RETRIEVE) FOR REJECTED IMAGES" HAS BEEN DISABLED FOR THIS SPECIFIC E-FILM WORKSTATION. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER MERGED THE INCORRECT DATA AND REJECTED THE ORIGINAL IMAGES AFTER THE MERGE, HOWEVER, THE CUSTOMER DID NOT CORRECT THE DICOM TAGS ON THE REJECTED IMAGES. THE NODE FOR E-FIRM (NON-GE REMOTE WORKSTATION) HAD THE PERMISSION TO REQUEST REJECTED IMAGES. CUSTOMER QUERIED E-FILM FOR IMAGES AND VIEWED REJECTED IMAGES WITH INCORRECT TAGS. SURGERY WAS PERFORMED ON THE WRONG PATIENT DUE TO INCORRECT IMAGE MERGE. THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY PACS SYSTEM PACS SERVER LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS 3.0.3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other E-FILM WORKSTATION