inforMED
MalfunctionDTY

TERUMO CDI 100 MONITOR

Received Sep 12, 2011 · Event occurred Aug 18, 2011

Report 1828100-2011-02752 · MDR key 2254878

Device

Generic name

Monitor

Model number

100

Catalog number

100

Product problems

  • Failure to Charge

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

Description of Event or Problem

DURING SETUP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE DEVICE DISPLAYED A BATTERY LOW ERROR MESSAGE. THE USER ATTEMPTED TO CHARGE THE BATTERY OVERNIGHT, BUT THE BATTERY DID NOT HOLD THE CHARGE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.