BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1141183 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24427
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP FOUND A BAD SYSTEM HDD. THE FLUORO STOPS WORKING AFTER SOME CINE RUNS ARE SELECTED. THE CUSTOMER IS STILL USING THE SYSTEM. THE GE REP ORDERED A HDD AND SOFTWARE FLOPPIES. HE REMOVED AND REPLACED HDD AND LOADED REL 14 SW. THE REP RESTORED NODES AND REFORMATTED THE CIN DRIVE. THE SYSTEM FUNCTIONS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TROUBLE RETRIEVING CINE RUNS. THEY WERE HAVING TO REBOOT THE SYSTEM. THE PROBLEM BEGAN AFTER A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1