BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRICITY RA1000

    MDR report key: 1143715 · Received August 29, 2008

    Report

    Report Number
    3004526608-2008-00043
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    September 18, 2007
    Report Date
    September 18, 2007
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    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 IN APRIL 2008. UPON INVESTIGATION, IT WAS DETERMINED THAT THERE WAS NO DEFECT IN THE SOFTWARE FOR THIS PRODUCT. THE SOFTWARE WAS DETERMINED THAT TRANSFERRING THE IMAGES TO THE TDK CD BURNER CAUSED TO IMAGES TO REVERT TO THEIR ORIGINAL ORIENTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS OPERATED ON THE WRONG SIDE, AFTER CT SINUS IMAGES WERE SENT FROM CT TO THE PACS TO THE TDK CD BURNER. THE SINUS IMAGES WERE ACQUIRED WITH THE PATIENT IN A PRONE POSITION, AND A SAVE STATE IS MADE ON THE CT SCANNER. THE IMAGES DISPLAY AS DESIRED ON PACS AS DEFAULT DISPLAY PROTOCOLS ARE CONFIGURED TO FLIP THE IMAGES. THE CUSTOMER THEN SENDS THE IMAGES FROM PACS TO THE CD BURNER WHERE THE IMAGE REVERTED TO ITS ORIGINAL ORIENTATION.

    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 Hospitalization TDK CD BURNER