BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXAVUE

    MDR report key: 25112790 · Received May 7, 2026

    Report

    Report Number
    3008776287-2026-00144
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 7, 2026
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    KQM
    UDI-DI
    00724995220570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 CAMERA WAS NOT PROPERLY CONNECTED TO THE NETWORK ADAPTOR OF THE HEXAVUE IP CUSTOM ROOM RACK. TO RESOLVE THE ISSUE, THE TECHNICIAN REBOOTED THE CAMERA AND THEN RE-CONNECTED THE CAMERA TO THE NETWORK ADAPTOR. THE HEXAVUE IP CUSTOM ROOM RACK 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 THEIR HEXAVUE IP CUSTOM ROOM RACK WAS UNABLE TO CAPTURE IMAGES WITH THE CAMERA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268507 HEXAVUE IP CUSTOM ROOM RACK KQM BLACK DIAMOND VIDEO, INC. HEXAVUE IP (10)2.2.0 00724995220570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown