BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXAVUE

    MDR report key: 25116978 · Received May 7, 2026

    Report

    Report Number
    3008776287-2026-00146
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 7, 2026
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    KQM
    UDI-DI
    00724995220594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE HEXAVUE IP CUSTOM ROOM RACK AND WAS ABLE TO DUPLICATE THE ISSUE. FOLLOWING THE TECHNICIAN'S TROUBLESHOOTING, HE FOUND THAT THE AVC-X WAS SHUTTING DOWN CAUSING THE TOUCH PANEL ISSUE. TO RESOLVE THE ISSUE WITH THE AVC-X AND TOUCH PANEL, THE UNINTERRUPTIBLE POWER SUPPLY (UPS) WAS REPLACED. THE TECHNICIAN REPLACED THE UPS, TESTED THE FUNCTION AND OPERATION OF THE HEXAVUE IP CUSTOM ROOM RACK, CONFIRMED IT TO BE OPERATING TO SPECIFICATION, AND RETURNED THE DEVICE TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE TOUCH PANEL WAS NOT DISPLAYING PROPERLY, CAUSING A DELAY OF PROCEDURE. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182221 HEXAVUE IP CUSTOM ROOM RACK KQM BLACK DIAMOND VIDEO, INC. HEXAVUE IP (10)3.2.0 00724995220594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown