BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 1083878 · Received July 28, 2008

    Report

    Report Number
    1720753-2008-24022
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP REPLACED THE FOOTSWITCH. HE TESTED THE FOOTSWITCH WITH NO FURTHER PROBLEMS. SYSTEM OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM CONTINUES TO FLUORO AFTER FOOTSWITCH IS RELEASED. THE FOOTSWITCH IS STUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1