BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1031047 · Received April 17, 2008

    Report

    Report Number
    1720753-2008-20663
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 14, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP ADJUSTED MAX DOSE OUTPUT ON NORMAL FLUORO FROM 9.66 R/MIN TO 8.75 R/MIN AND ON HLF MODE FROM 19.58 R/MIN TO 17.55 R/MIN. SYSTEM FUNCTIONS AS INTENDED, CASE CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MAX OUTPUT ON HLF WAS OVER THE 20 R/MIN LIMIT.

    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