BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2041080 · Received March 23, 2011

    Report

    Report Number
    1720753-2011-02333
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    April 26, 2010
    Report Date
    March 23, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE X-RAY INDICATOR ERROR MESSAGE. THE ISOLATION TRANSFORMER STRAPPING WAS ADJUSTED. THE FLUORO FUNCTION BOARD VOLTAGE WAS ADJUSTED. THE POWER MOTOR BOARD FUSES WERE RE-SEATED. THE SYSTEM CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED. THIS IS A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER THE FOOT PEDAL WAS RELEASED THE 9900 SYSTEM CONTINUED TO SOUND THE AUDIBLE INDICATOR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1