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

Model Number	HARMONY IQ 3600
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their harmony iq3600 integration system unit rebooted without command during a patient procedure causing a short procedure delay.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and found that the cpu stack cooling fan required replacement.After further investigation, the technician found that the air vents for the system were covered by boxes causing the unit to overheat.The technician removed the boxes from the vents to allow for airflow to enter the unit.The harmony iq3600 integration system operator manual states, "do not block any ventilation openings.Install in accordance with the manufacturer's instructions" to resolve the issue, the technician replaced the cpu cooling fan, tested the unit, confirmed it to be operating according to specification, and returned it to service.The technician counseled user facility personnel on the proper use and operation of harmony iq3600 integration system, specifically on the importance of ventilation.No additional issues have been reported.

• Brand Name: HARMONY IQ
• Common Device Name: INTEGRATION SSYSTEM
• 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: 24580593
• Report Number: 3008776287-2026-00065
• Device Sequence Number: 21430398
• Product Code: FTA
• UDI-Device Identifier: 00724995199142
• UDI-Public: (01)00724995199142((10)4.3.7.4
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/12/2026

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: 02/16/2026
• Initial Report FDA Received Date: 03/12/2026
• 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