inforMED
MalfunctionDTY

TERUMO CDI 100 MONITOR

Received Mar 31, 2011 · Event occurred Mar 7, 2011

Report 1828100-2011-00773 · MDR key 2068288

Device

Generic name

Monitor

Model number

100

Catalog number

100

Product problems

  • Fracture
  • Leak/Splash

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 BATTERY WAS CRACKED AND LEAKED ACID. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.