BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1070780 · Received July 9, 2008

    Report

    Report Number
    1720753-2008-22791
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 23, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE SYSTEM WAS BEING USED IN A CASE WHEN THE IMAGE WENT TO GRAY. REBOOT DID NOT HELP. AFTER A TWENTY MINUTE DELAY THEY WERE ABLE TO COMPLETE THE CASE WITH ANOTHER C-ARM.

    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