BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVIDIMAGE 4K

    MDR report key: 24958744 · Received April 22, 2026

    Report

    Report Number
    3008776287-2026-00121
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 22, 2026
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    KQM
    UDI-DI
    00724995195113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 MNA CABLES WERE IMPROPERLY SECURED RESULTING IN THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN SECURED/TIGHTENED THE MNA CABLES. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. A 3-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE IMAGE TO THEIR VIVIDIMAGE 4K SURGICAL MONITOR INTERMITTENTLY TURNED ON AND OFF RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189316 VIVIDIMAGE 4K SURGICAL DISPLAY KQM BLACK DIAMOND VIDEO, INC. RLM314K3 00724995195113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown