BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1970131 · Received January 14, 2011

    Report

    Report Number
    1720753-2011-00294
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 14, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND INSPECTED THE X-RAY TUBE HIGH VOLTAGE CONNECTIONS. DISCOVERED EVIDENCE OF HIGH VOLTAGE ARCING ON ANODE CONNECTOR. CLEANED AND SEALED BOTH CONNECTORS AND TUBE WELLS. UNIT NOW PASSES HIGH VOLTAGE ARC TESTS WITHOUT MALFUNCTION. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE SYSTEM MADE A POPPING NOISE FROM THE X-RAY TUBE END OF C-ARM AND SHUT DOWN. 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