MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Sep 19, 2011 · Event occurred Aug 25, 2011
Report 1828100-2011-02851 · MDR key 2275638
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 POWER UP AND WOULD NOT STAY ON IF LEFT RUNNING FOR A LONG PERIOD OF TIME. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.