BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2043021 · Received March 25, 2011

    Report

    Report Number
    9680959-2011-00878
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 25, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP CONDUCTED AN ONSITE INVESTIGATION. THE IMAGE PROCESSOR COMPUTER CARDS WERE RESEATED. THE POWER SUPPLY WAS CHECKED AND THE PC GUARD WAS DEACTIVATED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 7900 SYSTEM WOULD NOT BOOT 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