BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSPEED

    MDR report key: 1854178 · Received September 3, 2010

    Report

    Report Number
    2126677-2010-00006
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K082761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE HAS INITIATED AN INVESTIGATION OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE BEGINNING OF THE SECOND PHASE OF A (B)(6) STUDY, THE CT TABLE STOPPED ADVANCING WHILE THE X-RAY CONTINUED FOR ITS PRESCRIBED TIME. THERE WAS NO REPORT OF ANY DETERMINISTIC EFFECTS FROM THIS RADIATION EXPOSURE. THE PT IS NOT EXPECTED TO EXHIBIT ANY DETERMINISTIC EFFECTS SINCE THE DELIVERED DOSE FOR THIS STUDY WAS SIGNIFICANTLY BELOW THE THRESHOLD FOR DETERMINISTIC EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSPEED JAK GE MEDICAL SYSTEMS, LLC 5124069 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR