MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Sep 19, 2011 · Event occurred Aug 25, 2011
Report 1828100-2011-02852 · MDR key 2275637
Device
Generic name
Interface Module
Manufacturer
Terumo Cardiovascular System Corp.Model number
101Catalog number
101
Product problems
- No Display/Image
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 THE SCREEN INTERMITTENTLY TURNED OFF. 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
(B)(4) - SCREEN.