BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSTAR

    MDR report key: 1220655 · Received October 31, 2008

    Report

    Report Number
    9680959-2008-00211
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 30, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    1ST PROBLEM: THE GE REP INSTALLED A NEW IMAGE TO THE HARD DISC DRIVE (WADI-TOOL). THIS DID NOT HELP. SO HE CHANGED THE HARD DISC DRIVE AND CONFIGURED THE SYSTEM NEW. THEN THE SYSTEM RUN FOR ONE WEEK. 2ND PROBLEM: HE CHANGED THE BIOS-BATTERY FROM THE IPC, INSTALLED A NEW BIOS-SETUP (WADI-TOOL) AND CONTROLLED THE BIOS-SETUP FOR THE RIGHT IPC. THE SYSTEM RAN. AFTER CHECKING THIS, THEY BROUGHT THE DEVICE BACK IN THE OPERATING THEATER. THERE THE PROBLEM APPEARED AGAIN. SO HE CHECKED THE LINEVOLTAGE FROM THE HOSPITAL - O.K. I CHECKED THE POWER DISTRIBUTION TO THE IPC AND THE BIOS CONFIGURATION. THE SYSTEM-FAILURE IS NOT REPRODUCABLE.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED TWO PROBLEMS: 1ST: BOOT-PROBLEMS WITH THE FLUOROSTAR; THE CUSTOMER COMPLAINS THAT SOMETIMES DURING THE BOOT-UP PROCESS, THE COUNTER GOES TO ZERO AND THE DISPLAY RESTS IN THE BOOT-SCREEN. THE CUSTOMER STARTS (RESETS) THE BOOT-PROCESS AGAIN AND THEN THE SYSTEM RUNS. 2ND: IPC DOESN'T WORK CORRECT. THE CUSTOMER DESCRIBED THAT WHEN THE SYS IS BOOTED UP / RUNS, THEN SOMETIMES AN ACOUSTIC ALARM-SIGNAL SOUNDS, THE RESET-BUTTON IS FLASHING AND ALSO ALL RIGHT BUTTONS ARE FLASHING TOO ALTERNATELY - THAT MEANS, THE IPC IS REBOOTING AGAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1