MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Apr 8, 2011 · Event occurred Mar 16, 2011
Report 1828100-2011-00890 · MDR key 2078192
Device
Product problems
- Calibration Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE MONITOR KEPT RECALIBRATING. THE MONITOR WAS POWERED OFF A FEW TIMES TO RECALIBRATE AND ALWAYS CAME UP WITH A READING BUT DID NOT STORE VALUES. WITHIN A COUPLE MINUTES THE WHITE CALIBRATION TOUCH SCREEN DISPLAYED PLUS SIGNS. THE DEVICE WAS NOT CHANGED OUT, AND THE PROCEDURE CONTINUED WITHOUT DELAY. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO A PT DURING THIS EVENT.