MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-18 for SORIN S3 BUBB DET SENSOR, LOW LEVEL II 23-27-40 manufactured by Livanova Deutschland.
[139219691]
There was no patient involvement. Livanova (b)(4) manufactures the s3 bubb det sensor, low level ii. The incident occurred in (b)(6). Through follow-up communication with the technician in charge, livanova (b)(4) learned that the reported failure could not be reproduced and no deviations could be identified upon visual inspection and functional verification. The device has been requested back for further investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[139219692]
Livanova (b)(4) received a report of a s3 bubb det sensor, low level ii error message during setup. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2019-00164 |
| MDR Report Key | 8428266 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-18 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-04-03 |
| Device Manufacturer Date | 2012-12-03 |
| Date Added to Maude | 2019-03-18 |
| 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 | NJEMILE CRAWLEY |
| Manufacturer Street | 14401 W. 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 2812287575 |
| Manufacturer G1 | LIVANOVA DEUTSCHLAND |
| Manufacturer Street | LINDBERGHSTR. 25 |
| Manufacturer City | MUNICH 89309 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 89309 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SORIN S3 BUBB DET SENSOR, LOW LEVEL II |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | DTW |
| Date Received | 2019-03-18 |
| Model Number | 23-27-40 |
| 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 89309 GM 89309 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-18 |