MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Nov 18, 2011 · Event occurred Oct 21, 2011
Report 1828100-2011-03673 · MDR key 2361900
Device
Product problems
- Failure To Run On AC/DC
- Failure to Power Up
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE UNIT WILL NOT START UP WITH BATTERY IN; BUT WILL BOOT UP WITHOUT BATTERY. THE DEVICE WAS NOT CHANGED OUT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.