HV1000 INTEGRATION SYSTEM
Received Apr 16, 2026 · Event occurred Mar 18, 2026
Report 3008776287-2026-00114 · MDR key 24898468
Device
Generic name
Integration System
Manufacturer
Black Diamond Video, Inc.Product problems
- Display or Visual Feedback Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION OF THE REPORTED EVENT IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE. UDI RELATED DATA CLARIFICATION - THIS INTEGRATION SYSTEM QUALIFIES AS A MEDICAL DEVICE DATA SYSTEM (MDDS) AND THEREFORE UDI IS NOT IN GUDID.
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES, THE MONITORS CONNECTED TO FOUR OF THEIR HV1000 INTEGRATION SYSTEMS (SERIAL NUMBERS (B)(6), AND (B)(6)) ARE NOT SHOWING IMAGES. THE PROCEDURES WERE COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.