MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Dec 7, 2012 · Event occurred Nov 1, 2012
Report 1828100-2012-01534 · MDR key 2867819
Device
Product problems
- Crack
- Leak/Splash
- Failure to Power Up
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE UNIT WOULD NOT TURN ON. THEN IT WAS NOTICED THE MONITOR'S BATTERY WAS CRACKED AND LEAKING. AS A RESULT AN ALTERNATE BATTERY WAS USED FOR THE MONITOR. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS, BUT NOT YET COMPLETE.