inforMED
MalfunctionDTY

TERUMO CDI 101 MONITOR

Received May 27, 2011 · Event occurred May 5, 2011

Report 1828100-2011-01524 · MDR key 2118050

Device

Generic name

Monitor

Model number

101

Catalog number

101

Product problems

  • Corroded

Patient

Not reported

  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

Description of Event or Problem

DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN REPORTED THAT THE INTERFACE MODULE CABLE ASSEMBLY WAS CORRODED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.