BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1110308 · Received August 14, 2008

    Report

    Report Number
    1720753-2008-23936
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 23, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP REPLACED THE GENERATOR INTERFACE BOARD, ERASED FLASH, THEN RELOADED CAL FILES, UNIT OPERATES ERROR FREE IN HIGH-LEVEL FLUORO. HE CHECKED UNIT OPERATIONS, UNIT FUNCTIONS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE C-ARM DOES NOT OPERATE AT HIGH-LEVEL FLUORO, HOWEVER, THE UNIT IS FULLY FUNCTIONAL WHEN USED IN FLUORO MODE. THE CUSTOMER STATED THAT THE PROBLEM OCCURRED IN PREPARATION FOR PROCEDURE. AN ALTERNATIVE UNIT WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1