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	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that at the start of a patient procedure there was a loss of video input while using their harmony iq3600 integration system.The procedure was moved to a different room resulting in a procedure delay.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and was able to duplicate the reported event.To resolve the issue, the technician replaced the ori hard drive, tested the unit, confirmed it to be operating according to specifications, and returned it to service.The unit was manufactured in 2018 making it approximately 8 years old.No additional issues have been reported.
Additional Manufacturer Narrative
Contrary to mdr number 3008776287-2026-00058-01, the ori hard drive did not require replacement.To resolve the issue, the technician replaced the video input card, tested the unit, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.

• 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: 24530794
• Report Number: 3008776287-2026-00058
• Device Sequence Number: 18366389
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2026

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: 02/04/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/26/2026; 04/20/2026
• 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