BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1232518 · Received November 13, 2008

    Report

    Report Number
    1720753-2008-28058
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 13, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER 13219214. THE GE SERVICE REP INSPECTED THE 9800 SYSTEM AND PLAYED BACK MULTIPLE CINE RUNS, BUT COULD NOT DUPLICATE THE PROBLEM. ALL CINE RUNS WERE PLAYING BACK NORMAL. HE FORMATTED THE CINE DRIVE AND RECORDED AND PLAYED BACK MULTIPLE IMAGES. THE CINE RUNS ARE OPERATING AS NORMAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM IS NOT LOADING CINE RUNS PROPERLY. THE CASE WAS ABLE TO BE COMPLETED AFTER THE SYSTEM WAS REBOOTED. THERE WAS NO INJURY TO THE PATIENT.

    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