BEUDAMED
    FDA Adverse Event Other Summary report: N

    CT BRAIN PERFUSION

    MDR report key: 3044214 · Received April 1, 2013

    Report

    Report Number
    2134213-2013-00003
    Event Type
    Other
    Date Received
    April 1, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    VITAL IMAGES, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K121213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE ISSUE IS THE USER WAS ATTEMPTING TO LOAD AN UNSUPPORTED "AXIAL TWIST" DATASET AROUND THE Z-AXIS, WHICH WAS BLOCKED BY THE SOFTWARE. THIS PRODUCT LIMITATION IS ALREADY NOTIFIED TO USERS BY THE RELEASE NOTE ((B)(4)) PROVIDED WITH THE SOFTWARE.

    Description of Event or Problem · 1

    A NEUROLOGIST AT A MEDICAL CARE FACILITY WAS ASSESSING A PT PRESENTING WITH STROKE SYMPTOMS AND AN ACUTE ARTERIAL OCCLUSION. THE DOCTOR WAS USING A VITREA CT BRAIN PERFUSION FOR RISK/BENEFIT DETERMINATIONS FOR INTERVENTION DECISIONS BASED ON THE STATE OF INFARCT BRAIN TISSUE. THE FACILITY WAS UNABLE TO LOAD A BRAIN PERFUSION STUDY TO THE VITREA CT BRAIN PERFUSION APPLICATION. BASED ON AVAILABLE CTA RESULTS AND CLINICAL PRESENTATION OF THE PT, THE DOCTOR DECIDED TO INTERVENE AND SURGICALLY REMOVE A BRAIN CLOT. THE PT LATER DEVELOPED BLEEDING ON THE BRAIN AS A COMPLICATION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132755 CT BRAIN PERFUSION PICTURE ARCHIIVING AND COMMUNICATION SYSTEM LLZ VITAL IMAGES, INC. 6.3

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other