inforMED
MalfunctionDTY

TERUMO CDI 100 MONITOR

Received Aug 23, 2011 · Event occurred Aug 2, 2011

Report 1828100-2011-02556 · MDR key 2256383

Device

Generic name

Monitor

Model number

100

Catalog number

100

Product problems

  • Material Integrity Problem

Patient

Not reported

  • No Patient Involvement

Narrative

Description of Event or Problem

DURING ROUTINE TESTING OF THE DEVICE AT THE SVC CTR, THE SVC TECH REPORTED THAT THE BATTERY DOOR WAS DAMAGED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

Additional Manufacturer Narrative

EVAL IN PROGRESS, BUT NOT YET CONCLUDED.