BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXAVUE

    MDR report key: 24965172 · Received April 23, 2026

    Report

    Report Number
    3008776287-2026-00123
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 23, 2026
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    KQM
    UDI-DI
    00724995220594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 FOUND THAT THE USB-X OF THE RACK WAS NOT OPERATING PROPERLY. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE TOUCH PANEL. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED 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 TO THEIR HEXAVUE IP CUSTOM ROOM RACK WAS NOT RESPONDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625982 HEXAVUE CUSTOM ROOM RACK KQM BLACK DIAMOND VIDEO, INC. HEXAVUE IP (10)2.2.0 00724995220594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown