OtherKRL
STOCKERT S3 BUBBLE DETECTOR
Received Sep 2, 2014 · Event occurred Aug 5, 2014
Report 1718850-2014-00316 · MDR key 4071196
Device
Generic name
Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Manufacturer
Sorin Group DeutschlandModel number
23-07-50Catalog number
NA
Lot number
NA
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
SORIN GROUP RECEIVED A REPORT THE SORIN S3 BUBBLE DETECTOR WAS MALFUNCTIONING DURING A PROCEDURE. THERE WAS NO REPORT OF PT INJURY.
Additional Manufacturer Narrative
SORIN GROUP (B)(4) MANUFACTURES THE SORIN S3 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(6). THE MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.
Remedial action
- Other