BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1014250 · Received March 12, 2008

    Report

    Report Number
    1720753-2008-17922
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 11, 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 SERVICE REP RELOADED 6.15.3 SOFTWARE. VERIFIED SYSTEM BOOT UP AND FLUORO WITH NO ERRORS. ADJUSTED BRIGHTNESS AND CONTRAST SETTING ON PRINTER. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    SITE REPORTED SYSTEM WOULD NOT BOOT PAST 5 ARROWS. SYSTEM WAS REMOVED FROM ROOM. CASE WAS COMPLETED USING ANOTHER C-ARM. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY REPORTED. THE LEFT SIDE DEBUG MONITOR SHOWS: NO DHCP OR PROXYDHCP OFFERS WERE RECEIVED. RETRYING NETWORK BOOT. THEN SHOWS THE CLIENT MAC ADDRESS. SYSTEM REQUIRES A SOFTWARE RELOAD. SITE ALSO REPORTED THE SONY 980 PRINTER IS PRINTING DARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1