inforMED

HARMONY IQ 2800 INTEGRATION SYSTEM

Received Dec 19, 2014 · Event occurred Nov 20, 2014

Report 1000404456-2014-00012 · MDR key 4347105

Device

Generic name

Integration System

Product problems

  • No Display/Image

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR MONITORS WOULD GO BLANK FOR A FEW SECONDS.

Additional Manufacturer Narrative

INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

A STERIS FIELD SERVICE TECHNICIAN ARRIVED AT THE FACILITY, INSPECTED THE INTEGRATION SYSTEM AND FOUND THE PREVIEW IMAGE WAS FROZEN ON THE DISPLAY MONITOR. THE TECHNICIAN RESTARTED THE INTEGRATION SYSTEM WHICH RESOLVED THE ISSUE.

Description of Event or Problem

NO INJURIES WERE REPORTED; THE PROCEDURE WAS COMPLETED SUCCESSFULLY.