BEUDAMED
    FDA Adverse Event Death Summary report: N

    HI SPEED CT/I

    MDR report key: 1210683 · Received October 20, 2008

    Report

    Report Number
    1210683
    Event Type
    Death
    Date Received
    October 20, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 20, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC.
    Product Code
    JAK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED VIA EMS TO EMERGENCY DEPARTMENT. UNRESPONSIVE ON ARRIVAL AND HAD BEEN FOUND DOWN IN HIS APARTMENT BY FRIENDS. CODED ON ARRIVAL. ASSESSED WITH NEURO COMPLICATIONS AND SENT FOR CT SCAN. CT TECH CALLED ED STATING, "SCANNER WENT DOWN DURING PROCEDURE." UNABLE TO COMPLETE SCAN. HAD TO ARRANGE FOR PATIENT TO BE TRANSPORTED TO ANOTHER FACILITY FOR CT AND NEURO EVAL. TOOK ABOUT 1 HOUR WHICH DELAYED TREATMENT. DIAGNOSED WITH EXTENSIVE INTRACRANIAL BLEED. PT DIED AT SECOND FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI SPEED CT/I CT SCANNER, HIGH SPEED JAK GE MEDICAL SYSTEMS, LLC. HISPEED CT/I (COULD NOT BE VERIFIED) *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death