BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1481775 · Received July 17, 2009

    Report

    Report Number
    9680959-2009-00334
    Event Type
    Malfunction
    Date Received
    July 17, 2009
    Date of Event
    July 9, 2009
    Report Date
    July 15, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP READJUSTED THE IRIS AND DAP AFTER A QUALITY TEST. THE DAP WAS RE-CALIBRATED, HE CLOSED THE IRIS, AND ADJUSTED THE DOSE READER. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE IRIS AND DAP DISPLAYED ERRORS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1