MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Oct 13, 2011 · Event occurred Sep 12, 2011
Report 1828100-2011-03010 · MDR key 2315095
Device
Product problems
- Data Problem
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 MONITOR WOULD NOT STORE VALUES. THE DEVICE TURNED OFF AND ON A COUPLE OF TIMES. 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.