BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXAVUE

    MDR report key: 25060666 · Received May 1, 2026

    Report

    Report Number
    3008776287-2026-00142
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 1, 2026
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    FTA
    UDI-DI
    00724995198503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 CABLING REQUIRED REPLACEMENT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE USB CABLING. THE TECHNICIAN TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED THE UNIT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THEY WERE UNABLE TO CONNECT TO THE TOUCH PANEL ON THEIR HEXAVUE CUSTOM ROOM RACK. NO REPORT OF INJURY OR PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623266 HEXAVUE CUSTOM ROOM RACK FTA BLACK DIAMOND VIDEO, INC. HEXAVUE-SCC 1.0 (10)2.2.0 00724995198503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown