BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSPEED

    MDR report key: 3237848 · Received July 17, 2013

    Report

    Report Number
    2126677-2013-00013
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K030420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FLUORO SHIELD E3051AP WAS MANUFACTURED BY AADCO MEDICAL, INC. (PART S-745HL) AND DISTRIBUTED BY (B)(4). (B)(4) INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE TECH WAS MOVING THE BOOM ARM AWAY FROM THE TABLE OF A LIGHTSPEED SYSTEM THE ARM TO THE FLUORO SHIELD BROKE AND FELL OFF CAUSING THE 50LB LEADED PLEXIGLASS TO BREAK. NO INJURY WAS REPORTED FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332378 LIGHTSPEED COMPUTED TOMOGRAPHY SYSTEM JAK GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1