MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-11 for S3 BUBBLE DETECTOR 23-07-50 manufactured by Livanova Deutschland.
Report Number | 9611109-2019-00809 |
MDR Report Key | 9178245 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2019-10-11 |
Date of Report | 2019-10-10 |
Date of Event | 2018-01-18 |
Date Mfgr Received | 2018-01-18 |
Device Manufacturer Date | 2015-05-21 |
Date Added to Maude | 2019-10-11 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | ENRICO GRECO |
Manufacturer Street | 14401 W. 65TH WAY |
Manufacturer City | ARVADA CO 80004 |
Manufacturer Country | US |
Manufacturer Postal | 80004 |
Manufacturer G1 | LIVANOVA DEUTSCHLAND |
Manufacturer Street | LINDBERGHSTR. 25 |
Manufacturer City | MUNICH 80309 |
Manufacturer Country | GM |
Manufacturer Postal Code | 80309 |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | S3 BUBBLE DETECTOR |
Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
Product Code | KRL |
Date Received | 2019-10-11 |
Model Number | 23-07-50 |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | LIVANOVA DEUTSCHLAND |
Manufacturer Address | LINDBERGHSTR. 25 MUNICH 80309 GM 80309 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-10-11 |