BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1000591 · Received February 21, 2008

    Report

    Report Number
    1720753-2008-16322
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 21, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED POPPING NOISE COULD NOT BE DUPLICATED. HOWEVER, ADJUSTED THE DRIVE PULSE DEAD TIME AND PERFORMED A FILAMENT CALIBRATION. THE VIDEO CABLE ON THE BACK OF THE WORKSTATION WAS REPLACED. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYS MADE A POPPING NOISE DURING FLUORO. IT WAS ALSO NOTED THAT THE VIDEO CONNECTOR ON THE BACK OF THE WORKSTATION IS BROKEN. PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI