MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Jan 31, 2011 · Event occurred Jan 6, 2011
Report 1828100-2011-00096 · MDR key 1981609
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 Patient Involvement
Narrative
Description of Event or Problem
DURING ROUTINE TESTING OF THE DEVICE, THE USER REPORTED THE INTERFACE MODULE DID NOT FUNCTION AS EXPECTED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.