BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 1150883 · Received September 9, 2008

    Report

    Report Number
    1720753-2008-24728
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 14, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS REPAIRED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE. SYSTEM ROTATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE C-ARM ONLY ROTATES ONE DIRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600+ FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1