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	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The technician tested the unit and found that the 4k card was not working properly.To resolve the issue, the technician replaced the 4k card.The unit was tested, confirmed to be operating according to specification, and returned to service.No additional issues have been reported.
Event or Problem Description
A steris service technician reported observing flickering on the monitors attached to the user facility's harmony iq integration system.No report of injury.

• 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: 24766448
• Report Number: 3008776287-2026-00095
• Device Sequence Number: 21120385
• Product Code: FTA
• UDI-Device Identifier: 00724995199142
• UDI-Public: (01)00724995199142(10)RL0010F36BC5DF
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HARMONY IQ 3600
• Device Catalogue Number: RLQ3600SLC
• Device Lot Number: (10)RL0010F36BC5DF
• 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: 03/04/2026
• Initial Report FDA Received Date: 04/02/2026
• 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