MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Jul 3, 2012 · Event occurred Jun 5, 2015
Report 1828100-2012-00964 · MDR key 2647769
Device
Product problems
- Failure to Charge
- Material Rupture
- Battery Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THE UNIT WAS NOT CHARGING. THE BATTERY HAD EXPLODED ON ONE SIDE OF THE BATTERY. THE CUSTOMER WAS UNCERTAIN WHEN THIS ISSUE WAS REALIZED BUT REPORTED; "AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED AND THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES AS A RESULT".
Additional Manufacturer Narrative
INVESTIGATION IN PROCESS, BUT NOT YET COMPLETED.