MAUDE Adverse Event Report: BLACK DIAMOND VIDEO, INC. HEXAVUE; CUSTOM ROOM RACK

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	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, the monitors connected to their hexavue ip custom room rack went "black" and the nurse station monitor, mouse control and touchscreen went "black".The procedure was completed successfully following a short delay.No report of injury.
Additional Manufacturer Narrative
User facility personnel stated that during the time of the reported event they rebooted the avc-x component and the monitors connected to their hexavue ip custom room rack and nurse station equipment were displaying properly; no black displays were present.A steris service technician arrived onsite following the reported event and found no issues with the function or operation with the hexavue ip custom room rack or associated equipment; the reported event could not be duplicated.The technician returned the devices to service, and no additional issues have been reported.

• Brand Name: HEXAVUE
• Common Device Name: CUSTOM ROOM RACK
• 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: 25477132
• Report Number: 3008776287-2026-00299
• Device Sequence Number: 13052619
• Product Code: KQM
• UDI-Device Identifier: 00724995220587
• UDI-Public: (01)00724995220587(10)2.2.0
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 06/11/2026

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: XQHPSLC
• 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: 05/15/2026
• Initial Report FDA Received Date: 06/11/2026
• 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