BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2192847 · Received July 25, 2011

    Report

    Report Number
    1720753-2011-20402
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 25, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE FILAMENT DRIVER PRINTED CIRCUIT BOARD WAS REPLACED AND THE FILAMENT WAS CALIBRATED. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A FILAMENT ERROR, THE EXPOSURE SWITCH STUCK AND THE LIFT FAILED DURING A PROCEDURE. 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