BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAIN LAB IMAGING SYSTEM

    MDR report key: 22131163 · Received June 2, 2025

    Report

    Report Number
    MW5171002
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Report Date
    May 30, 2025
    Manufacturer
    BRAINLAB AG
    Product Code
    QIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE SITE HAVING ISSUES UPLOADING PATIENT EXAMS USING A DISK. THE IMAGES WOULD UPLOAD ONTO THE S8 BUT GIVE THE "DATA NOT VALID FOR NAVIGATION" ERROR. THE CS NOTED THE EXAMS WERE LIKELY NOT TAKEN FOLLOWING THE IMAGING PROTOCOL. THERE WERE TWO EXAM SETS ON THE DISK, BOTH USING THE BRAIN LAB IMAGING SYSTEM AND HAVING 384 SLICES, BUT WHEN UPLOADED ONTO THE STEALTH, THE SYSTEM WOULD REPORT AN ERROR STATING THAT A MINIMUM OF 3 SLICES WAS NEEDED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887830 BRAIN LAB IMAGING SYSTEM AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE QIH BRAINLAB AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown