MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Oct 13, 2011 · Event occurred Sep 14, 2011
Report 1828100-2011-03037 · MDR key 2315026
Device
Generic name
Power Suply
Manufacturer
Terumo Cardiovascular System CorpModel number
5310Catalog number
5310
Product problems
- Material Protrusion/Extrusion
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem
DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN REPORTED THAT THE RED POWER LIGHT EMITTING DIODE WAS PUSHED IN ON POWER SUPPLY. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.