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	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress; a follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported via vigilance report that their surgical display screen "turned black" during a patient procedure while using their harmony iq integration system resulting in a procedure delay.No report of injury.
Additional Manufacturer Narrative
Steris has been in contact and actively working with (b)(6) regarding reported issues with their steris operating room equipment.It should be noted that this is the only customer reporting this issue to date with the steris system and not all ors at the facility equipped with the system have had issues.We will continue our investigation activities and troubleshooting to determine a root cause and resolve the reported issue.To further troubleshoot a resolution for the issue, steris will install 4k cards in the ors.The 4k cards allow for direct fiber connections to monitors which will reduce the components between the monitors and integration system.Following installation, the systems will be monitored to determine if the 4k cards reduce the issue.Steris is actively working with the customer to scheduled time to install the 4k cards.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
Steris is actively working with the customer to schedule time to install the 4k cards.The 4k card is scheduled to be installed in or5 today, (b)(6) 2025.The remaining 8 ors are pending available dates from the customer.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The 4k card has been installed in or1 subject of this report.Steris has continued to monitor the performance of the devices with the customer since the installation of the 4k card.To date, there have been no recurrences of the reported issue with the 4k card installed.At this time, no further action will be taken as no additional issues have been reported.Steris will continue to monitor for similar events to ensure the product continues to perform as expected.

• 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 ; 4403927453
• MDR Report Key: 21412481
• Report Number: 3008776287-2025-00003
• Device Sequence Number: 18273653
• Product Code: FTA
• UDI-Device Identifier: 00724995199142
• UDI-Public: (01)00724995199142
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 02/19/2025

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
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/30/2025; 06/27/2025; 08/27/2025
• 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