MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Dec 6, 2011 · Event occurred Oct 20, 2011
Report 1828100-2011-03900 · MDR key 2399311
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE MONITOR WAS SHOWING ERRATIC FAULTS. THERE WAS A BRIEF DELAY DURING PREPARATION. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.