BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1076006 · Received July 16, 2008

    Report

    Report Number
    1720753-2008-20981
    Event Type
    Malfunction
    Date Received
    July 16, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 24, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP INSPECTED THE UNIT. THE VERTICAL LIFT INTERMITTENTLY DOES NOT WORK. THE SERVICE REP TROUBLESHOOT, SYSTEM REQUIRES NEW PS3 PWR SUPPLY. HE REMOVED THE FAULTY PS3 PWR SUPPLY AND INSTALLED NEW PS3 POWER SUPPLY. VERIFIED PROPER OPERATION OF VERTICAL LIFT. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VERTICAL COLUMN PROBLEM HAPPEN DURING A CASE. THE CASE WAS COMPLETED. NO PT WAS INJURED.

    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