BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1040812 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21385
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 8, 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 COULD NOT DUPLICATE THE PROBLEM. THE SYSTEM WAS WORKING AS INTENDED. CUSTOMER HAS USED UNIT WITH NO REOCCURENCE OF ISSUE. GOING TO MONITOR FOR A FEW DAYS TO SEE IF PROBLEM REOCCURS. CALLED CUSTOMER BACK AND THERE IS NO REPORT OF REOCCURRENCE OF ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN IMAGE QUALITY ISSUE. 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