BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1153644 · Received September 11, 2008

    Report

    Report Number
    1720753-2008-22277
    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
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP CONFIRMED THE ERROR VIA THE ERROR LOGS. HE WAS UNABLE TO DUPLICATE THE PROBLEM. HE COMPLETED A LOAD TEST ON BATTERIES, BATTERY VOLTAGE MAINTEINED ABOVE 170 VDC DURING TEST, BATTERIES O.K. THE REP CALIBRATED THE CHARGER PCB PER MFR SPEC. HE FOUND NORMAL CHARGING VOLTAGE AT 229 VDC, ADJUSTED FOR 225 VDC. ERROR LOGS REVEALED POSSIBLE CORRUPT NODES ON MAINFRAME. THE REP FLASHED AND RELOADED NODES AND CALIBRATION FILES. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING THE END OF CASE, SYSTEM MAINFRAME DISPLAYED "CHARGER FAILURE ERROR." THE TECH RE-BOOTED SYSTEM WITHOUT ERROR AND WAS ABLE TO COMPLETE CASE WITH SYSTEM. DEFECT DELAYED CASE WITHOUT ANY PT INJURIES.

    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