inforMED
MalfunctionDTY

TERUMO CDI 100 MONITOR

Received May 23, 2011 · Event occurred Apr 27, 2011

Report 1828100-2011-01448 · MDR key 2102664

Device

Generic name

Monitor

Model number

100

Catalog number

100

Product problems

  • Battery Problem

Patient

Not reported

  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

Description of Event or Problem

DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER REPORTED THAT THE UNIT WAS NOT OPERATIONAL. A BATTERY REPLACEMENT WAS REQUESTED AND SENT. SINCE THE EVENT OCCURRED DURING A NON-CLINICAL ACTIVITY, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.