BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISPEED FXI

    MDR report key: 1172856 · Received September 19, 2008

    Report

    Report Number
    9612283-2008-00004
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    GE YOKOGAWA MEDICAL SYSTEMS, LTD.
    Product Code
    JAK
    PMA / PMN Number
    K980169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE ENGINEERING INVESTIGATION FOUND THAT ONE OF THE FOUR BOLTS HOLDING THE HEAT EXCHANGER TO THE TUBE WAS MISSING. ENGINEERING ALSO INVESTIGATED THE POTENTIAL FOR THE ISSUE TO RESULT IN HOT OIL TO CONTACT THE PATIENT AND FOR THE POTENTIAL FOR THE HEAT EXCHANGER OR THE FAN TO BREACH THE GANTRY COVER. ENGINEERING INVESTIGATION CONFIRMED THAT IT IS HIGHLY UNLIKELY FOR THIS ISSUE TO RESULT IN PARTS BREACHING THE GANTRY COVERS. HOWEVER, SINCE THE ISSUE CAN CAUSE A GAP BETWEEN THE MYLAR WINDOW AND THE FRONT AND/OR REAR COVER, THERE IS POTENTIAL FOR THE HOT OIL TO DRIP ONTO THE PATIENT ON THE TABLE WHEN THE TUBE STOPS AT ABOUT 12 O'CLOCK POSITION. THERE HAVE BEEN NO OTHER SIMILAR INSTANCES REPORTED OUT OF A LARGE NUMBER OF INSTALLED BASE SYSTEMS IN THE PAST DECADE.

    Description of Event or Problem · 1

    IT WAS REPORTED AT THIS SITE THAT THE HEAT EXCHANGER HIT THE SIDE OF THE GANTRY DURING A PATIENT EXAM AND THE GANTRY ROTATION STOPPED. THIS CAUSED THE GANTRY SIDE COVER TO CRACK OPEN, THE FAN ASSEMBLY ON THE HEAT EXCHANGER TO BREAK INTO PIECES, AND THE HOSE ON THE REAR SIDE OF THE HEAT EXCHANGER TO BREAK OFF. THE BROKEN PIECES OF THE FAN ASSEMBLY AND OIL SPILLED ONTO THE FLOOR. THE FRONT COVER ON THE SIDE WAS PUSHED OUTWARD TOWARD THE TABLE, CREATING A WIDER GAP IN THE GANTRY APERTURE THUS CAUSING THE MYLAR WINDOW TO NO LONGER SEAT PROPERLY BETWEEN THE FRONT AND REAR COVERS. NO INJURY WAS REPORTED. GE ENGINEERING INVESTIGATION CONFIRMED THAT IT IS HIGHLY UNLIKELY FOR THIS ISSUE TO RESULT IN PARTS BREACHING THE GANTRY COVER. HOWEVER, THERE IS A POTENTIAL FOR THE HOT OIL TO CONTACT THE PATIENT DUE TO THE GAP AND THIS COULD RESULT IN SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HISPEED FXI JAK GE YOKOGAWA MEDICAL SYSTEMS, LTD. 2201000

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR