BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIVUE COMPUTERIZED COGNITIVE ASSESSMENT AID

    MDR report key: 22213229 · Received June 16, 2025

    Report

    Report Number
    MW5171507
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Report Date
    May 30, 2025
    Manufacturer
    COGNIVUE, INC.
    Product Code
    PKQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DEVICE STARTED SMOKING WITH CUSTOMER AND NO ACTION WAS TAKEN. POOR DOCUMENTATION SUCH AS INCOMPLETE SIGNATURES, USE OF RED PEN, NOT INITIAL AND DATING MISTAKES NON-CONFORMING PRODUCT IS PUT UPSTAIRS HIDDEN AND NOT DEALT WITH IN THE CORRECT WAY, BIRDS CONSISTENTLY GET IN FACILITY AND DEFECATE ON THE WALLS, AND DEVICES WERE SENT TO THE UK WITHOUT PROPER UKCA MARK ON LABELS. LABELS THAT ARE ON DEVICES AND PAPERWORK AREN¿T CLEAR. "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
    987615 COGNIVUE COMPUTERIZED COGNITIVE ASSESSMENT AID COMPUTERIZED COGNITIVE ASSESSMENT AID PKQ COGNIVUE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown