BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1270860 · Received December 24, 2008

    Report

    Report Number
    1720753-2008-21337
    Event Type
    Malfunction
    Date Received
    December 24, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 6, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP ORDERED A NEW LEFT MONITOR. INSPECTION OF LOGS INDICATE OVERLOAD FAULTS DURING TIME OF REPORTED PROBLEM. THERE WERE ALSO FFB PSYNC ERRORS AND LOSS OF GEN NODE AT INTERMITTENT TIMES. HV TANK AND SNUBBER WERE CHANGED WITHIN PAST YEAR. ORDERED NEW X-RAY TUBE AND X-RAY CONTROLLER. INSTALLED NEW X-RAY TUBE AND X-RAY CONTROLLER. PERFORMED FILAMENT CAL IAW SERVICE MANUAL. SYSTEM OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEFT MONITOR WAS INTERMITTENTLY BLANKING OUT. 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