BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXAVUE

    MDR report key: 25008664 · Received April 27, 2026

    Report

    Report Number
    3008776287-2026-00131
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    October 27, 2024
    Report Date
    April 27, 2026
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    KQM
    UDI-DI
    00724995198503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 HEXAVUE CUSTOM ROOM RACK AND FOUND THAT THE POWER SUPPLY REQUIRED REPLACING. THE TECHNICIAN REPLACED THE POWER SUPPLY, TESTED THE FUNCTION AND OPERATION OF THE UNIT, CONFIRMED IT TO BE OPERATING 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 THE MINDRAY IMAGE CONNECTED TO THEIR HEXAVUE CUSTOM ROOM RACK HAS IMAGE DISTORTION. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26027 HEXAVUE INTEGRATION SYSTEM KQM BLACK DIAMOND VIDEO, INC. HEXAVUE SCC 1.0 (10)2.2.0 00724995198503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown