BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1040811 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21384
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP REGREASED THE HIGH VOLTAGE CABLE. HE DETERMINED THE SYSTEM HAD A BAD X-RAY TUBE, SO THE REP ORDERED A NEW X-RAY TUBE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM BEGAN "POP IN" WHEN FLUORING. ALSO, THE MONITOR GOES BLACK. NO PATIENT 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