MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Aug 8, 2011 · Event occurred Jul 11, 2011
Report 1828100-2011-02379 · MDR key 2210276
Device
Product problems
- Failure to Power Up
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE MONITOR WOULD NOT GO INTO OPERATE MODE. THE MACHINE WAS TURNED OFF AND ON SEVERAL TIMES AND IT CAME BACK ON AND WORKED FOR THE REST OF THE PROCEDURE. THE USER REPORTED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.