BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 1221545 · Received November 5, 2008

    Report

    Report Number
    9680959-2008-00213
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 9, 2008
    Report Date
    November 4, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP REPLACED THE IMAGE SYSTEM IPS200 AND VERIFIED THE SYSTEM BOOT AND FLUORO FUNCTION. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    AFTER COMPLETING SERVICE FOR A "NO POWER" ISSUE ON ANOTHER CASE, THE MONITOR HAD A ROLLING IMAGE DURING BOOT UP. BYPASSING THE IMAGE PROCESSOR ALLOWED PROPER IMAGE DISPLAYED. THE L2 BLINKED THREE TIMES INDICATING A RAM FAILURE ON PCB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1