BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT BRAIN PERFUSION

    MDR report key: 3040538 · Received March 8, 2013

    Report

    Report Number
    2134213-2013-00001
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    VITAL IMAGES, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K121213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE ISSUE IS THAT THE USER WAS ATTEMPTING TO SEND ACQUISITION DATA TO THE VITREA 2D BRAIN PERFUSION SOFTWARE FOR AN ACQUISITION METHOD, PHILIPS JOG MODE, THAT IS CURRENTLY NOT SUPPORTED BY THE VITREA SOFTWARE.

    Description of Event or Problem · 1

    AN ISSUE WAS RECEIVED BY A RADIOLOGIST AT A MEDICAL CARE FACILITY, WHO WAS CONCENTRATED ABOUT SLICE TO SLICE BRAIN PERFUSION VARIATIONS IN REVIEW OF AN ACQUISITION OBTAINED THROUGH USE OF PHILIPS JOG MODE BY CT BRAIN PERFUSION SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100588 CT BRAIN PERFUSION PICTURE ARCHIVING AND COMMUNICATIONS SYS LLZ VITAL IMAGES, INC. 6.2 SU03 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA