BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1153650 · Received September 11, 2008

    Report

    Report Number
    1720753-2008-22283
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 6, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP CHECKED THE SYSTEM AND FOUND THE SYSTEM WILL NOT BOOT UP WITH THE WARNING ON THE C-ARM (FILAMENT CALIBRATION REQUIRED AND COLLIMATOR CALIBRATION REQUIRED). UNABLE TO COPY THE DEBUGLOG FILE THE MESSAGE DATA ERROR READING DRIVE C WILL APPEAR ON THE DEBUG MONITOR, CHECKED THE RUS FILES AND FOUND THE MA LIMIT HAS BEEN ERASED. FOUND THE POWER CABLE CUT. REPLACED DISK DRIVE, FORMATTED AND PARTITIONED, SYSTEM 9800 FOR THE DATA BASE CORRUPTION ERROR. REPLACED ASM, CABLE, PWR CORD, 110 V 15 AMP. 100-127 V SETTING, 20', NON-EMI, 9800/6800/9900 AND ASM, PCB, GEN INTERFACE, 9800/9900 FOR THE MA FILE ISSUE. PERFORMED A GENERATOR CALIBRATION. SYSTEM FUNCTIONAL CHECKED. IMAGE RESOLUTION. AUTO KVP MEASURED. ARE WITH SPECIFICATIONS. ALL C-ARM AND WORKSTATION CONTROLS FUNCTIONING PROPERLY. OVERALL SYSTEM OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERROR ON THE RIGHT MONITOR WHEN BOOTING THE SYSTEM. THE CUSTOMER HAD TO SHUT DOWN THE C-ARM AND REBOOT TO COMPLETE THE CASE. A PT WAS INVOLVED BUT NOT INJURED.

    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