MalfunctionKRL
TERUMO ULTRASONIC AIR SENSOR
Received Aug 9, 2006 · Event occurred Jul 11, 2006
Report 1828100-2006-00303 · MDR key 762873
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Lot number
NA
Product problems
- Sensor problems
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING PREPARATION FOR AND DURING CARDIOPULMONARY BYPASS, THE AIR DETECTION SENSOR COULD NOT BE RESET. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION ANTICIPATED, BUT NOT YET BEGUN.