MalfunctionDTY
TERUMO CDI 100 MONITOR
Received May 21, 2013 · Event occurred Apr 30, 2013
Report 1828100-2013-00528 · MDR key 3130100
Device
Product problems
- Failure to Power Up
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE USER FACILITY'S HEART PROGRAM WAS BEING RESTARTED AND THE PERFUSIONIST (CCP) WAS CHECKING THE EQUIPMENT. WHEN THE UNIT WOULD NOT TURN ON, THEY NOTICED THE BATTERY WAS OLD AND LOOKED TO BE LEAKING.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE MONITOR WOULD NOT TURN ON. THE UNIT HAS BEEN IN STORAGE. THERE WAS NO PT INVOLVEMENT.