HARMONY IQ INTEGRATION SYSTEM
Received Jun 17, 2026 · Event occurred May 18, 2026
Report 3008776287-2026-00529 · MDR key 25537995
Device
Generic name
Integration System
Manufacturer
Black Diamond Video, Inc.Model number
HARMONY IQ 3600Catalog number
RLQ3600SLC
Lot number
(10)4.3.7.0
Product problems
- Display or Visual Feedback Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE HARMONY IQ INTEGRATION SYSTEM AND FOUND THE MONITOR NEEDED TO BE REBOOTED. TO RESOLVE THE ISSUE THE TECHNICIAN REBOOTED THE MONITOR, TESTED THE FUNCTION AND OPERATION OF THE UNIT, CONFIRMED IT TO BE OPERATING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THE MONITOR TO THEIR HARMONY IQ INTEGRATION SYSTEM WAS NOT COMMUNICATING TO THE BASE UNIT AND WAS NOT AVAILABLE ON THE TOUCHSCREEN DURING A PATIENT PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.