BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1014246 · Received March 12, 2008

    Report

    Report Number
    1720753-2008-17955
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 11, 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 SERVICE REP FOUND AN X RAY TUBE ARCHING. HE CLEANED AND LUBRICATED CANDLE STICKS. HE ALSO CHECKED VOLTAGES. ALL OK. THE REP CHECKED SYSTEM BATTERIES READING LOW. HE ORDERED BATTERIES, WILL RETURN TO INSTALL BATTERIES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED MA ERRORS WHILE FLUORING IN HIGH TECHNIQUE WITH HEAVY PATIENT. NO INJURIES WERE 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