MalfunctionDTY
TERUMO CDI 101 MNITOR
Received Aug 9, 2011 · Event occurred Jul 15, 2011
Report 1828100-2011-02380 · MDR key 2219906
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 GO INTO OPERATE MODE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE USER REPORTED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.