MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Jan 20, 2012 · Event occurred Dec 8, 2011
Report 1828100-2012-00062 · MDR key 2442616
Device
Product problems
- Device Inoperable
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE MONITOR WAS NOT WORKING CORRECTLY. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAY OR ADVERSE CONSEQUENCES TO THE PT.
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.