MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Apr 17, 2012 · Event occurred Mar 23, 2012
Report 1828100-2012-00313 · MDR key 2547943
Device
Product problems
- Crack
- Device Displays Incorrect Message
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THAT THE BATTERY HAS A PHYSICAL CRACK IN IT WITH RESIDUE. THE MONITOR WAS DISPLAYING A "REPLACE BATTERY" MESSAGE ALSO. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.
Additional Manufacturer Narrative
THE REPORTED COMPLAINT WAS CONFIRMED. THE CUSTOMER REPLACED THE BATTERY AND RETURNED THE OLD BATTERY TO THE MANUFACTURER FOR DISPOSAL. NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME.