BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 6600

    MDR report key: 1083805 · Received July 29, 2008

    Report

    Report Number
    1720753-2008-24013
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE IMAGE INTENSIFIER COVER. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A HOLE WAS DRILLED IN THE IMAGE INTENSIFIER COVER DURING A PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 6600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1