inforMED
MalfunctionDTY

TERUMO CDI 100 MONITOR

Received Jun 14, 2011 · Event occurred May 19, 2011

Report 1828100-2011-01658 · MDR key 2176029

Device

Generic name

Monitor

Model number

100

Catalog number

100

Product problems

  • Failure to Power Up

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 THAT THE MONITOR WOULD NOT TURN ON. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.