BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXAVUE

    MDR report key: 24955419 · Received April 22, 2026

    Report

    Report Number
    3008776287-2026-00120
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 22, 2026
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    KQM
    UDI-DI
    00724995220594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND FOUND THAT THE MEDICAL NETWORK ADAPTER (MNA) WAS NOT OPERATING. DURING THE TECHNICIANS INSPECTION HE FOUND THAT THE FAN WITHIN THE MNA WAS NOT WORKING SUBSEQUENTLY CAUSING THE MNA TO OVERHEAT RESULTING IN THE REPORTED EVENT. THE TECHNICIAN REPLACED THE MNA, TESTED THE FUNCTION AND OPERATION OF THE DEVICE, CONFIRMED IT TO BE OPERATING TO SPECIFICATIONS AND RETURNED THE UNIT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE MONITOR CONNECTED TO THEIR HEXAVUE IP CUSTOMER ROOM RACK WAS NOT DISPLAYING AN IMAGE. THE EVENT DID NOT OCCUR DURING A PATIENT PROCEDURE. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272913 HEXAVUE CUSTOM ROOM RACK KQM BLACK DIAMOND VIDEO, INC. HEXAVUE IP (10)3.0.0 00724995220594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown