HARMONY IQ 3600 INTEGRATION SYSTEM
Received Jan 9, 2015 · Event occurred Dec 11, 2014
Report 1000404456-2015-00001 · MDR key 4404300
Device
Generic name
Integration System
Manufacturer
Vts Medical SystemsProduct problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED DURING A PATIENT PROCEDURE, ONE OF THEIR IN-FIELD MONITORS WENT OUT. NO INJURIES OR PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.
Additional Manufacturer Narrative
A STERIS FIELD SERVICE TECHNICIAN ARRIVED ONSITE, INSPECTED THE UNIT, AND WORKED WITH A MEMBER OF THE ORI TEAM TO TEST THE FACILITY WIRING AND INTEGRATION SYSTEM. THE TECHNICIAN IDENTIFIED AN ARC WITHIN THE UNIT. A SHORT WAS OCCURRING BETWEEN THE RED POWER CABLE FOR THE MONITOR AND THE GROUNDING SPRING CABLE THAT IS ROUTED IN THE MESH COVER AS A PART OF THE WIRING BUNDLE FOR THE BOOM. WHEN THE CABLE CAME IN CONTACT WITH THE SPINDLE, THE SYSTEM EXPERIENCED AN ELECTRICAL SHORT. THE TECHNICIAN REPLACED THE CPU STACK, THE MONITOR CABLE, AND THE SERIAL BOARD. THE TWO MONITORS WILL ALSO BE REPLACED TO ENSURE THE SYSTEM WILL BE OPERATING ACCORDING TO SPECIFICATION.