BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1852208 · Received September 29, 2010

    Report

    Report Number
    1720753-2010-03278
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 29, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND ERASED AND REBUILT GENERATOR AND FLUORO FUNCTIONS BOARD NODES, RELOADED CONFIGURATION DATA. VERIFIED SYSTEM BOOTS WITHOUT ERROR AND MAKES X-RAY WITHOUT ISSUE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SYSTEM BOOTED WITH DATA ERROR DISPLAYED, PREVENTING COMPLETION OF BOOT UP. 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