BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1220625 · Received October 31, 2008

    Report

    Report Number
    9617766-2008-01403
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 28, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP COULD NOT DUPLICATE THE PROBLEM. NO PROBLEM REPORTED IN ERROR LOGS. CUSTOMER SHOT 1.0SEC IN PULSE MODE, POSSIBLY NOT ENOUGH EXPOSURE FOR UNIT TO TRACK IN PULSE. HE REMINDED THE CUSTOMER THAT AVERAGING IS TURNED OFF DURING PULSE TO CAUSE GRAINY IMAGE. UNIT FULLY FUNCTIONAL AND OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED POOR IMAGE QUALITY, DARK AND GRAINY IMAGES. THE CUSTOMER REBOOTED THE UNIT AND COMPLETED THE PROCEDURE WITHOUT PATIENT INJURY. THE CUSTOMER WAS IN PULSE MODE WHEN THE PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1