BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1221547 · Received November 5, 2008

    Report

    Report Number
    9617766-2008-01418
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 5, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP INSTALLED THE SBC COMPATIBILITY KIT SOFTWARE 4.8.34 RELEASE 14. THE SYSTEM IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DOES NOT BOOT UP, AND BOTH MONITOR ARE BLACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1