BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1071122 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22901
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP INITIALLY REPLACED THE BATTERY PACK. AFTER ANOTHER REPORT OF THE SAME FAILURE, THE GE SERVICE REP CONDUCTED A GENERATOR AND DOSE CALIBRATION. THE SYSTEM WORKED FINE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED POOR IMAGE QUALITY. 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