MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Jul 12, 2011 · Event occurred Jun 17, 2011
Report 1828100-2011-02006 · MDR key 2182277
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 WHEN YOU TURN THE MONITOR ON, A BLANK SCREEN APPEARED AND BEEPED CONTINUOUSLY. THE DISPLAY PREVIOUSLY CAME UP IN GERMAN. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.