BEUDAMED
    FDA Adverse Event Other Summary report: N

    GE PROTEUS AND/OR CARESTREAM X-RAY SYSTEMS

    MDR report key: 2253457 · Received September 14, 2011

    Report

    Report Number
    1717855-2011-00002
    Event Type
    Other
    Date Received
    September 14, 2011
    Date of Event
    June 16, 2011
    Report Date
    August 5, 2011
    Manufacturer
    GE HEALTHCARE,
    Product Code
    KOP
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    NOTE: THIS EVENT WAS ORIGINALLY FILED ON (B)(4) 2011, UNDER FORM 3500. VARIAN MEDICAL SYSTEMS RECEIVED A GE (B)(4) RELOAD WITH A VARIAN A-195 INSERT FOR FAILURE ANALYSIS. THE CUSTOMER (B)(6), RETURNED THIS TUBE UNIT TO VARIAN WITH THE X-RAY TUBE SERVICE REPORT STATING THAT, "OIL HEATED UP ENOUGH TO MELT THE PLASTIC/ACRYLIC PORT. THIS ALLOWED ALL OF THE OIL TO DRAIN OUT OF THE TUBE INTO THE COLLIMATOR." UNDER THE HEADING REASON FOR RETURN, THE BOX "OIL LEAK" WAS CHECKED AND ALSO THE "OTHER" STATED, "SHATTERED INSERT." REP FROM VARIAN, (B)(6), GE, AND (B)(4) MET ON CONFERENCE CALLS ON (B)(6) 2011. FROM THESE DISCUSSIONS, IT WAS DISCOVERED THAT THE GE PROTEUS SYSTEM HAD AN OLD VERSION OF SOFTWARE (VER. 5.57) INSTALLED ON IT THAT WAS KNOWN TO CAUSE THIS TYPE OF FAILURE. GE'S RECORDS SHOW A SOFTWARE UPDATE TO VERSION 5.59 IN 2009 TO PREVENT THIS TYPE OF KNOWN FAILURE. (B)(6) IS RESPONSIBLE FOR SERVICING THEIR OWN MACHINES, AND COULD NOT ACCOUNT FOR THE V 5.57 SOFTWARE ON THE PROTEUS SYSTEM AT THE TIME OF THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE PROTEUS AND/OR CARESTREAM X-RAY SYSTEMS X-RAY SYSTEMS KOP GE HEALTHCARE,

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOADED INTO A GE (B)(4) HOUSING.| VARIAN X-RAY TUBE UNIT, A-195, SERIAL#(B)(4),