MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Nov 18, 2011 · Event occurred Oct 21, 2011
Report 1828100-2011-03677 · MDR key 2361913
Device
Generic name
Interface Module
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
7101Catalog number
7101
Product problems
- Device Operates Differently Than Expected
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 INTERFACE MODULE WAS NOT WORKING. 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 PATIENT AS A RESULT OF THIS EVENT.