MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Aug 16, 2011 · Event occurred Jul 22, 2011
Report 1828100-2011-02448 · MDR key 2239132
Device
Generic name
Power Supply
Manufacturer
Terumo Cardiovascular System Corp.Model number
5310Catalog number
5310
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR NON-CLINICAL ACTIVITY, THE USER REPORTED THAT THE ALTERNATING CURRENT POWER LIGHT DID NOT WORK. THERE IS NO BATTERY. SINCE THE EVENT OCCURRED DURING A NON-CLINICAL ACTIVITY, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.