BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1232522 · Received November 13, 2008

    Report

    Report Number
    1720753-2008-28064
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 13, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE GE SERVICE REP REPLACED THE P4 POWER SUPPLY AND VERIFIED THE SYSTEM BOOT AND FLUORO FUNCTION. HE VERIFIED THE COLLIMATOR FUNCTIONED. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A COLLIMATOR POTENTIOMETER ERROR AND NO FLUORO PRIOR TO THE CYSTO CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1