MalfunctionKRL
TERUMO ULTRASONIC AIR SENSOR
Received Jul 20, 2006 · Event occurred Jun 20, 2006
Report 1828100-2006-00276 · MDR key 741426
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Lot number
NA
Product problems
- Sensor problems
- Device Issue
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING PREPARATION FOR AND DURING CARDIOPULMONARY BYPASS, THE AIR DETECTION SENSOR DID NOT FUNCTION, REQUIRING IT TO BE REMOVED FROM SERVICE. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION ANTICIPATED BUT NOT YET BEGUN.