BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1031040 · Received April 17, 2008

    Report

    Report Number
    1720753-2008-20671
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 14, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING DEBUG ANALYSIS, A GIB WITH NODE FAILURE WAS FOUND. THE SVC REP REPLACED THE GIB THEN RELOADED NODES AND CALIBRATION FILES. SYS FIVE VOLT TO GIB PCB AT 5.15VDC. SYS OPERATING WITHIN MFR SPEC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS HAS LOST COMMUNICATION, WILL NOT FLUORO, AND HAS A BOOTUP FAILURE. NO PT INJURY WAS REPORTED.

    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