MAUDE Adverse Event Report: BLACK DIAMOND VIDEO, INC. HARMONY IQ; INTEGRATION SYSTEM

Model Number	HARMONY IQ 3600
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: HARMONY IQ
• Common Device Name: INTEGRATION SYSTEM
• Manufacturer (Section D): BLACK DIAMOND VIDEO, INC.; 503 canal blvd.; richmond CA 94804
• Manufacturer (Section G): BLACK DIAMOND VIDEO, INC.; 503 canal blvd.; richmond CA 94804
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24984721
• Report Number: 3008776287-2026-00126
• Device Sequence Number: 21243194
• Product Code: FTA
• UDI-Device Identifier: 00724995199142
• UDI-Public: (01)00724995199142(10)4.3.7.4
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HARMONY IQ 3600
• Device Catalogue Number: RLQ3600SLC
• Device Lot Number: (10)4.3.7.4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown