MalfunctionDTY
TERUMO CDI 540 CALIBRATOR
Received Apr 12, 2011 · Event occurred Mar 18, 2011
Report 1828100-2011-00907 · MDR key 2062323
Device
Generic name
Calibrator
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
151802Catalog number
151802
Product problems
- Low Readings
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem
UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT MIXED GAS A/D WAS TOO LOW (19 INSTEAD OF MINIMAL 21). THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.