BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 1882949 · Received October 15, 2010

    Report

    Report Number
    9680959-2010-00415
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 15, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM, REPLACED HARD DRIVE, RELOADED SOFTWARE, BUT DID NOT CORRECT THE PROBLEM. SENT ERROR LOGS TO TECHNICAL SUPPORT TEAM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM INTERMITTENTLY WILL NOT COMPLETE BOOT UP. IF SYSTEM BOOTS UP, WITHIN A FEW MINUTES THE SYSTEM LOCKS UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1