BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXAVUE

    MDR report key: 25123667 · Received May 8, 2026

    Report

    Report Number
    3008776287-2026-00147
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    KQM
    UDI-DI
    00724995220594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TOUCH PANEL TO THEIR HEXAVUE IP CUSTOM ROOM RACK WENT BLACK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305291 HEXAVUE IP CUSTOM ROOM RACK KQM BLACK DIAMOND VIDEO, INC. HEXAVUE IP (10)2.2.0 00724995220594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown