MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Apr 19, 2011 · Event occurred Mar 25, 2011
Report 1828100-2011-00991 · MDR key 2094182
Device
Product problems
- No Display/Image
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem
DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE MONITOR DISPLAY FAILED TO APPEAR WHEN POWERED ON, AND MADE A LONG BEEPING NOISE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.