BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1220644 · Received October 31, 2008

    Report

    Report Number
    9617766-2008-01386
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 24, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP RETRIEVED LOG FILES. HE VERIFIED POWER SUPPLY VOLTAGES, ERASED/FLASHED NODES, RESEATED THE PCB'S, FLEXED THE INTERCONNECT AND HIGH VOLTAGES CABLES DURING EXPOSURES. THE IMAGE RESOLUTION AND AUTO TECHNIQUE TRACKING PASSED. HE RELOADED THE WORKSTATION SYSTEM SOFTWARE VERSION 4.8.13. THE SYSTEM IS NOW SAVING PT IMAGES. COULD NOT DUPLICATE ORIGINAL REPORTED PROBLEM. THE SYSTEM IS CURRENTLY OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT POOR IMAGE QUALITY. ALSO THE SYSTEM WAS NOT SAVING PATIENT'S IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1