HV1000 INTEGRATION SYSTEM
Received May 9, 2025 · Event occurred Mar 20, 2025
Report 3008776287-2025-00005 · MDR key 21997265
Device
Generic name
Integration System
Manufacturer
Black Diamond Video, Inc.Product problems
- Display or Visual Feedback Problem
- Display or Visual Feedback Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE PANEL WAS NOT RESPONDING TO TOUCH. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE TOUCH PANEL. THE SYSTEM WAS RETURNED TO SERVICE. THE TOUCH PANEL SUBJECT OF THE REPORTED EVENT WILL BE RETURNED TO STERIS FOR EVALUATION. 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 APPLICABLE.
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TOUCH PANEL TO THEIR HV1000 INTEGRATION SYSTEM MONITOR WOULD NOT RESPOND TO COMMANDS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.
Additional Manufacturer Narrative
THE TOUCH PANEL SUBJECT OF THE REPORTED EVENT WAS RETURNED TO STERIS FOR EVALUATION, HOWEVER A CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE TOUCH PANEL. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. A 1-YEAR COMPLIANT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT.