MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Apr 15, 2011 · Event occurred Mar 23, 2011
Report 1828100-2011-00940 · MDR key 2074567
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem
THE USER REPORTED THAT IR1 READ 99.9%. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.