BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT BRAIN PERFUSION (4D BRAIN PERFUSION)

    MDR report key: 7231200 · Received January 31, 2018

    Report

    Report Number
    2134213-2018-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2018
    Date of Event
    January 4, 2018
    Report Date
    April 26, 2018
    Manufacturer
    VITAL IMAGES, INC
    Product Code
    LLZ
    PMA / PMN Number
    121213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    VITAL IMAGES HAS COMPLETED ITS INVESTIGATION INTO THE CANON MEDICAL SYSTEMS (FORMERLY (B)(6) SCANNER CHANGE. IN REVIEWING THE CHANGES AGAINST THE SUPPORTED ACQUISITIONS IN VITREA 4D BRAIN PERFUSION, IT HAS BEEN DETERMINED THERE IS NO ACCURACY OR SAFETY IMPACT. THERE HAVE BEEN NO CUSTOMER COMPLAINTS ASSOCIATED WITH THIS INVESTIGATION.

    Description of Event or Problem · 1

    VITAL IMAGES HAS BECOME AWARE OF A CHANGE IN HOW SOME CANON MEDICAL SYSTEMS (FORMERLY TOSHIBA MEDICAL SYSTEMS) SCANNERS HANDLE DICOM INFORMATION. THIS CHANGE MAY AFFECT THE ACCURACY OF PERFUSION RESULTS IN OUR 4D BRAIN PERFUSION SOFTWARE. VITAL IMAGES IS WORKING WITH CANON MEDICAL SYSTEMS TO BETTER UNDERSTAND THIS ISSUE AND DETERMINE ITS POTENTIAL IMPACT. TO DATE, THERE HAVE BEEN NO COMPLAINTS FILED AT VITAL ASSOCIATED WITH THIS ISSUE.

    Description of Event or Problem · 1

    VITAL IMAGES HAS BECOME AWARE OF A CHANGE IN HOW SOME CANON MEDICAL SYSTEMS (FORMERLY (B)(6) SCANNERS HANDLE DICOM INFORMATION. THIS CHANGE MAY AFFECT THE ACCURACY OF PERFUSION RESULTS IN OUR 4D BRAIN PERFUSION SOFTWARE. VITAL IMAGES IS WORKING WITH CANON MEDICAL SYSTEMS TO BETTER UNDERSTAND THIS ISSUE AND DETERMINE ITS POTENTIAL IMPACT. TO DATE, THERE HAVE BEEN NO COMPLAINTS FILED AT VITAL ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76096 CT BRAIN PERFUSION (4D BRAIN PERFUSION) PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM LLZ VITAL IMAGES, INC TBD N/A

    Patients

    Seq Age Sex Outcome Treatment
    1