BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2243637 · Received August 24, 2011

    Report

    Report Number
    1720753-2011-21320
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP REPLACED THE SURGE SUPPRESSOR BOARD, REROUTED DC VOLT HARNESS AND REPAIRED CONNECTIONS FROM DC SUPPLY TO COLLIMATOR NODE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM TABLE WOULD NOT MOVE, COMMUNICATION ERROR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1