BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 875391 · Received July 6, 2007

    Report

    Report Number
    1720753-2007-03018
    Event Type
    Malfunction
    Date Received
    July 6, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE REP EVALUATED SYSTEM AND REPLACED: SINGLE BOARD COMPUTER (SBC), IMAGE PROCESSOR PCB, DISPLAY ADAPTER PCB, VIDEO CONTROLLER OCB, AND THE HARD DRIVE. REP RELOADED CAL FILES AND OPERATIONALLY TESTED THE SYSTEM. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. NO PT INJURY REPORTED.

    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 YR