BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXAVUE

    MDR report key: 25095945 · Received May 6, 2026

    Report

    Report Number
    3008776287-2026-00143
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 6, 2026
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    KQM
    UDI-DI
    00724995220594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 AVC-X WAS NOT OPERATING PROPERLY. TO RESOLVE THE ISSUE, THE TECHNICIAN REBOOTED THE AVC-X. 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 PRIOR TO A PATIENT PROCEDURE THE FIELD MONITOR TO THEIR HEXAVUE IP CUSTOM ROOM RACK FROZE. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65918 HEXAVUE IP CUSTOM ROOM RACK KQM BLACK DIAMOND VIDEO, INC. HEXAVUE IP (10)2.2.0 00724995220594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown