MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Nov 5, 2010 · Event occurred Oct 13, 2010
Report 1828100-2010-02003 · MDR key 1899674
Device
Generic name
Monitor (power Supply)
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5310Catalog number
5310
Product problems
- Battery Problem
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER REPORTED THE BATTERY ONLY WORKED INTERMITTENTLY AND WOULD NOT TURN ON AT TIMES. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING A NON-CLINICAL ACTIVITY, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.