BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1071050 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22747
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 20, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP REPLACED THE POWER CONTROLLER BOARD, UNIT POWER UP ERROR FREE, CHECKED UNIT OPERATIONS, UNIT FUNCTIONS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE C-ARM DOES NOT POWER UP, HOWEVER, THE POWER INDICATION ON THE BACK OF THE WORKSTATION IS ON. DETERMINED BY THE IN HOUSE ENGINEER THAT PROBLEM CAUSED BY FAULTY POWER CONTROLLER BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1