MalfunctionDTY

TERUMO CDI 100 MONITOR

Received Feb 22, 2011 · Event occurred Jan 20, 2011

Report 1828100-2011-00363 · MDR key 2015644

Device

Generic name

Monitor

Manufacturer

Terumo Cardiovascular Systems Corp.

Model number

100

Catalog number

100

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 READ "99" ON SATURATIONS. THE USER WAS UNABLE TO RE-CALIBRATE. AS THIS FAILURE OCCURRED NEAR THE END OF THE PROCEDURE, THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.