MalfunctionDTY

TERUMO CDI 100 MONITOR

Received Mar 29, 2011 · Event occurred Mar 4, 2011

Report 1828100-2011-00742 · MDR key 2049824

Device

Generic name

Monitor

Manufacturer

Terumo Cardiovascular Systems Corp.

Model number

100

Catalog number

100

Product problems

Battery Problem

Patient

Not reported

No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED A BATTERY FAILURE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO ADVERSE CONSEQUENCES TO A PATIENT AS A RESULT OF THIS EVENT.