MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-12 for S5 BUBBLE DETECTOR 23-07-50 manufactured by Livanova Deutschland.
[72562675]
Patient information was not provided. Livanova (b)(4) manufactures the s5 bubble detector. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). A livanova field service representative was dispatched to the facility to investigate. The service representative tested the device extensively and was unable to reproduce the reported issue. Functional verification testing was successfully completed and the device was returned to service. As the issue could not be reproduced, a root cause could not be determined. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
Patient Sequence No: 1, Text Type: N, H10
[72562676]
Livanova (b)(4) received a report that the s5 bubble detector gave repeated false alarms and triggered multiple pump stops during a procedure. The procedure was completed with a spare sensor. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2017-00290 |
| MDR Report Key | 6485817 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-12 |
| Date of Report | 2017-04-12 |
| Date of Event | 2017-03-27 |
| Date Mfgr Received | 2017-03-27 |
| Device Manufacturer Date | 2013-12-13 |
| Date Added to Maude | 2017-04-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOAN CEASAR |
| Manufacturer Street | 14401 W. 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 2812287260 |
| Manufacturer G1 | LIVANOVA DEUTSCHLAND |
| Manufacturer Street | LINDBERGHSTR. 25 |
| Manufacturer City | MUNICH, 80939 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 80939 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S5 BUBBLE DETECTOR |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | KRL |
| Date Received | 2017-04-12 |
| Model Number | 23-07-50 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA DEUTSCHLAND |
| Manufacturer Address | LINDBERGHSTR. 25 MUNICH, 80939 GM 80939 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-12 |