MalfunctionKRL
TERUMO AIR BUBBLE DETECTOR
Received Oct 17, 2007 · Event occurred Sep 14, 2007
Report 1828100-2007-00370 · MDR key 930761
Device
Generic name
Air Sensor
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Product problems
- Sensor problems
Patient
YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING PREPARATION FOR USE OF THE DEVICE, THE AIR BUBBLE SENSOR DID NOT ALARM WHEN EXPOSED TO AN AIR BUBBLE. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION ANTICIPATED BUT NOT BEGUN.