BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONY IQ

    MDR report key: 24984721 · Received April 24, 2026

    Report

    Report Number
    3008776287-2026-00126
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    FTA
    UDI-DI
    00724995199142
    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 TO INSPECT THE HARMONY IQ INTEGRATION SYSTEM AND WAS ABLE TO DUPLICATE THE ISSUE. FOLLOWING THE TECHNICIAN'S TROUBLESHOOTING, HE FOUND THAT THE VIDEO CONVERTER TO THE DISPLAY REQUIRED REPLACEMENT. THE TECHNICIAN REPLACED THE VIDEO CONVERTER, TESTED THE FUNCTION AND OPERATION OF THE HARMONY IQ INTEGRATION SYSTEM, CONFIRMED IT TO BE OPERATING TO SPECIFICATION, AND RETURNED THE DEVICE TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED DURING A PATIENT PROCEDURE, AN EMPLOYEE ATTEMPTED TO ROUTE A VIDEO CONNECTION TO THE HARMONY IQ SYSTEM USING A VIDEO CONVERTER AND THE VIDEO SOURCE DID NOT DISPLAY ON THE MONITOR. THE EMPLOYEE USED A DIFFERENT VIDEO CONVERTER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY OR PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401559 HARMONY IQ INTEGRATION SYSTEM FTA BLACK DIAMOND VIDEO, INC. HARMONY IQ 3600 (10)4.3.7.4 00724995199142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown