BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1151084 · Received September 9, 2008

    Report

    Report Number
    1720753-2008-24771
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 15, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP ERASED FLASH AND RELOADED CAL FILES. HE CHECKED CONFIGURATION FILES FOR ACCURACY AND TESTED SYSTEM BY DOING SUBTRACTIONS OF A PHANTOM. SYSTEM OPERATING AS INTENDED UPON COMPLETION. SUBTRACTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WILL NOT SUBTRACT. THERE ARE BAD CONFIGURATION FILES.

    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