MalfunctionDTY

TERUMO CDI 100 MONITOR

Received Feb 22, 2011 · Event occurred Jan 13, 2011

Report 1828100-2011-00365 · MDR key 2015652

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 SATURATIONS READ "99". THE USER RE-CALIBRATED AND THE NORMAL READINGS RETURNED TO "99". THE USER RE-CALIBRATED AGAIN AND THE NORMAL READINGS STAYED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THE IS EVENT.