MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Jun 3, 2011 · Event occurred May 9, 2011
Report 1828100-2011-01552 · MDR key 2117620
Device
Product problems
- Improper Device Output
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE READING WERE INACCURATE. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.