MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-11 for S3 BUBBLE DETECTOR 23-07-50 manufactured by Livanova Deutschland.
[145972419]
There was no patient involvement. Livanova (b)(4) manufactures the s3 bubble detector. The incident occurred in (b)(6). A review of the dhr could not identify any deviations or nonconformities relevant to the issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[145972420]
Livanova (b)(4) received a report that a s3 bubble detector shut off during setup. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2019-00241 |
| MDR Report Key | 8503011 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-11 |
| Date of Report | 2019-08-13 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-07-18 |
| Device Manufacturer Date | 2016-05-20 |
| Date Added to Maude | 2019-04-11 |
| 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 | BARBARA GALASSO |
| 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 | S3 BUBBLE DETECTOR |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2019-04-11 |
| Model Number | 23-07-50 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA DEUTSCHLAND |
| Manufacturer Address | LINDBERGHSTR. 25 MUNICH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-11 |