BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1140887 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24324
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 25, 2008
    Report Date
    August 5, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP COULD NOT VERIFY ISSUE. HE CHECKED THE HIGH VOLTAGE CABLE AND FOUND NO SIGN OF ARCING. HE SPOKE WITH THE USER AND HE STATED THAT AFTER HEARING POPPING, THE UNIT NEEDED TO BE REBOOTED AND THEY WERE ABLE TO CONTINUE USE OF UNIT FOR SEVERAL CASES. THE GE SERVICE REP ORDERED A NEW X-RAY TUBE. HE REPLACED THE TUBE, PERFORMED A FILIMENT CAL, AND TESTED UNIT BY SHOOTING SEVERAL FLUORO IMAGES. NO ARCING WAS HEARD. THE UNIT WORKS AS NORMAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED AN OVERLOAD MESSAGE AND WAS MAKING A LOUD POP IN TUBE DURING THREE CASES. THEY WERE ABLE TO FINISH THE CASES WITHOUT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1