BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1083862 · Received July 29, 2008

    Report

    Report Number
    1720753-2008-24112
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 29, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SVC REP CHECKED THE AC AND DC VOLTAGES. HE ERASED AND RELOADED THE FLASH MEMORY THEN RELOADED THE CALIBRATIONS. THE OUTPUT OF CAMERA IS DEFECTIVE, SO HE ORDERED A NEW CAMERA TO REPLACE ON THE SYS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MONITOR GOES BLACK AND THE KV GOES TO MAX.

    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