BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1071042 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-20900
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 23, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP ORDERED A PS3 POWER SUPPLY FOR UP/DOWN MOVEMENT. THE REP REPLACED THE PS3 POWER SUPPLY. TESTED SAME WITH 10 UP/DOWN MOVEMENTS WITH NO PROBLEMS. SYSTEM FUNCTIONS AS INTENDED WITH NO ERRORS OR PROBLEMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE C-ARM INTERMITTENTLY WILL NOT GO UP AND DOWN. NO PT 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