BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2062110 · Received April 6, 2011

    Report

    Report Number
    1720753-2011-03311
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND FOUND THE X-RAY INDICATOR WAS BEEPING, BUT THE SYSTEM WAS NOT PRODUCING X-RAYS. THIS WAS REPORTED BY THE CUSTOMER. THERE WAS NO ACCIDENTAL RADIATION OCCURRENCE. THE GE REP REPLACED THE FLUORO FUNCTIONS BOARD, X-RAY CONTROLLER BOARD, PS1 POWER SUPPLY, BACKPLANE BOARD, AND THE WORKSTATION HARD DRIVE; RELOADED SOFTWARE AND THE BACKUP CALIBRATION FILES. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WAS PRODUCING X-RAYS ON ITS OWN. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1