BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1831858 · Received September 8, 2010

    Report

    Report Number
    1720753-2010-02974
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 8, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REGREASED THE CANDLESTICK (HIGH VOLTAGE) CONNECTORS, MADE A LONG EXPOSURE USING HIGH TECHNIQUES. NO ARCING OCCURRED AND LINE PAIR IMAGE WAS WITHIN SPECS. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISTORTION IN IMAGES AND X-RAY TUBE IS ARCING WHEN HIGH TECHNIQUES ARE USED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1