BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1070995 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-20572
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 10, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEM INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP INSTALLED THE NEW BATTERIES AND FILAMENT DRIVE BD. HE REGREASED CANDLE STICKS ON BOTH ENDS AND ADJUSTED 5VDC SUPPLY IN MF FROM 4.95 TO 5.1VDC. FOUND OVERTEMP WIRES PINCHED UNDER X-RAY TUBE AND CORRECTED. SYSTEM NOW WORKING PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND SAID THE SYSTEM IS GETTING A FILAMENT REGULATOR ERROR AND LO MA ERROS. THE SERVICE REP ARRIVED THAT SAME MORNING TO TEST THE SYSTEM AND FOUND BAD BATTERIES. WILL ORDER. A PAIN TREATMENT PROCEDURE WAS BEING STARTED AT THE TIME OF THE COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1