BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXAVUE

    MDR report key: 25184854 · Received May 15, 2026

    Report

    Report Number
    3008776287-2026-00150
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 15, 2026
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    KQM
    UDI-DI
    00724995198497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND WAS ABLE TO DUPLICATE THE REPORTED EVENT. FOLLOWING THE TECHNICIAN'S TROUBLESHOOTING, HE FOUND THAT THE CPU CARD AND FIBER CABLE REQUIRED REPLACEMENT. THE TECHNICIAN REPLACED THE CPU CARD AND FIBER CABLE, TESTED THE FUNCTION AND OPERATION OF THE HEXAVUE 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 SETUP PRIOR TO THE PATIENT PROCEDURE THE TOUCH PANEL WAS UNRESPONSIVE WHILE USING THEIR HEXAVUE CUSTOM ROOM RACK. THE PROCEDURE WAS MOVED TO A DIFFERENT ROOM RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87898 HEXAVUE CUSTOM ROOM RACK KQM BLACK DIAMOND VIDEO, INC. HEXAVUE SLC 1.0 (10)2.1.1 00724995198497

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown