MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Mar 28, 2013 · Event occurred Mar 11, 2013
Report 1828100-2013-00299 · MDR key 3035288
Device
Product problems
- Leak/Splash
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BATTERY WAS LEAKING OUT THE BACK OF THE BLOOD PARAMETER MONITOR (BPM). THE UNIT WAS NOT CHANGED OUT BECAUSE THEY DID NOT HAVE A BACKUP UNIT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.
Additional Manufacturer Narrative
EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.