MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Jul 1, 2011 · Event occurred Jun 7, 2011
Report 1828100-2011-01862 · MDR key 2177707
Device
Product problems
- Failure to Power Up
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE MONITOR WOULD NOT TURN ON. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.