BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSPEED QX/I

    MDR report key: 482102 · Received September 2, 2003

    Report

    Report Number
    2126677-2003-00011
    Event Type
    Malfunction
    Date Received
    September 2, 2003
    Date of Event
    June 2, 2003
    Report Date
    August 29, 2003
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME OF THE BOLTS SECURING THE PERFORMIX X-RAY TUBE TO THE ROTATING PART OF THE GANTRY SHEARED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSPEED QX/I CT JAK GE MEDICAL SYSTEMS, LLC 2281177 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening