BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1153624 · Received September 11, 2008

    Report

    Report Number
    1720753-2008-22274
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 6, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP INSTALLED A NEW HARDRIVE AND LOADED SOFTWARE. HE RELOADED CAL FILES, CHECKED THE UNIT BY SELECTING FUNCTIONS ON THE RIGHTHAND MONITOR AND ASSURING THAT THE UNIT REACTED PROPERLY. HE CHECKED AND ASSURED THAT THE SYSTEM WAS OPERATING ACCORDING TO MFR SPECS. UNIT WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHENEVER ATTEMPTING TO RETRIEVE A PT IMAGE, THE CART TAKES A LONG TIME TO RETRIEVE THE IMAGE. ALSO WHEN SELECTING A FUNCTION ON THE RIGHTHAND MONITOR, THE UNIT REACTS VERY SLOWLY. 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