BEUDAMED
    FDA Adverse Event Death Summary report: N

    GE LIGHTSPEED CT750 HD

    MDR report key: 4212667 · Received October 24, 2014

    Report

    Report Number
    2126677-2014-00020
    Event Type
    Death
    Date Received
    October 24, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K081105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE PROVIDED AFTER THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SERIOUSLY INJURED PT WAS ADMITTED TO THE TRAUMA ROOM OVERNIGHT. DURING THE PRESCRIBED CT SCAN, THE TABLE STOPPED AND COULD ONLY BE MOVED AFTER A RESTART. THE HOSP STATED THAT THE PT SUCCUMBED DUE TO THE SEVERITY OF THE INJURIES SUSTAINED PRIOR TO THE CT SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680081 GE LIGHTSPEED CT750 HD COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death