BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1873466 · Received September 20, 2010

    Report

    Report Number
    1720753-2010-03133
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 20, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND FOUND A BROKEN WIRE IN THE INTERCONNECT CABLE. THE CABLE WAS ORDERED AND THE CUSTOMER INSTALLED THE NEW CABLE. SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYS IS DISPLAYING A SYSTEM ERROR "POWER OFF WAIT 10 SEC" ON THE MAINFRAME DISPLAY AND INTERMITTENTLY THE C-ARM WOULD NOT BOOT. IT WOULD STOP AT 5 ARROWS ON THE DISPLAY. 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