MAUDE Adverse Event Report: BLACK DIAMOND VIDEO, INC. HEXAVUE; HEXAVUE IP INTEGRATION SYSTEM

Model Number	HEXAVUE IP
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and found that the avc-x component was not able to boot up as intended; no image was able to be populated on the monitor.The technician rebooted the avc-x component, tested the function and operation of the monitor and hexavue ip custom room rack, confirmed them to be operating to specifications and returned the devices to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that a monitor connected to their hexavue ip custom room rack would not display patient vitals.The event did not occur during a patient procedure.No report of injury.

• Brand Name: HEXAVUE
• Common Device Name: HEXAVUE IP 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: 24713312
• Report Number: 3008776287-2026-00086
• Device Sequence Number: 20274517
• Product Code: KQM
• UDI-Device Identifier: 00724995220587
• UDI-Public: (01)00724995220587(10)2.2.0
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/27/2026

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: HEXAVUE IP
• Device Catalogue Number: XQHPILCC
• Device Lot Number: (10)2.2.0
• 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: 02/25/2026
• Initial Report FDA Received Date: 03/30/2026
• 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