MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Sep 27, 2011 · Event occurred Aug 31, 2011
Report 1828100-2011-02941 · MDR key 2279621
Device
Product problems
- No Display/Image
- Ambient Noise 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 WHEN POWERING UP THE MONITOR, A CONSTANT BEEP HAS HEARD AND THE SCREEN WENT BLANK AND REBOOTED ITSELF. 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.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.