BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 1872313 · Received October 12, 2010

    Report

    Report Number
    9680959-2010-00388
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    October 5, 2009
    Report Date
    October 12, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO EVAL OF THE SYSTEM BY A GE REP. GE REP CONTACTED CUSTOMER BY PHONE AND CUSTOMER WAS ABLE TO FIX THE SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DATA WAS LOST AFTER A MOVE FROM ONE FACILITY TO ANOTHER. 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