MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Apr 12, 2011 · Event occurred Mar 18, 2011
Report 1828100-2011-00905 · MDR key 2062327
Device
Generic name
Interface Module
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
7101Catalog number
7101
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE BRACKET FELL OFF THE BACK OF THE BOARD. 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 A PT AS A RESULT OF THIS EVENT.