BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2193121 · Received July 22, 2011

    Report

    Report Number
    1720753-2011-20292
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 22, 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

    THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE BATTERY WAS REPLACED. THE CALIBRATION FILES WERE RELOADED AND THE FILAMENTS WERE CALIBRATED. THE FLASH MEMORY WAS REBUILT AND THE VOLTAGE WAS ADJUSTED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A GENERATOR ERROR MESSAGE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1