BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1070290 · Received July 9, 2008

    Report

    Report Number
    1720753-2008-20538
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 9, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEM INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AFTER A POWER OUTAGE, THE SYSTEM BOOTED UP WITH ALL LEDS LIT AND THE X-RAY LIGHT ON. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1