BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1040743 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21361
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP FOUND THAT THE DOSE RATE NORMAL MODE 8.4 R/MIN BOOST MODE 17.6 R/MIN. IMAGE FOCUSES NORMAL MODE 2.7 MAG 1: 3.2 MAG 2: 4.0 KV TRACKING 1 COPPER 65 2 COPPER 76 3 COPPER 83 ADJUSTED KV TRACKING IS TO HIGH AFTER ADJUSTMENT 1 COPPER 62 2 COPPER 73 3 COPPER 82 SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGE TAKEN ON A LARGER PATIENT WAS WASHED OUT GRAY. FOUND KV TRACING TO BE TO HIGH. NO PATIENT INJURY WAS REPORTED.

    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