MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-18 for S5 LEVEL SENSOR MODULE 23-40-20 manufactured by Livanova Deutschland.
[83215594]
There was no patient involvement. Livanova manufactures the s5 sensor module level. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). The module was returned to livanova (b)(4) for investigation. During the evaluation, the reported issue was reproduced. The level module did not show the state of the level in the main control display. Trouble shooting identified the cause of the issue to be corrupted data in the memory banks of the micro-controller on the board of the module. The nvmem module was flashed and a 3 day test run was conducted with the simulator switching between low and high levels every 5 seconds. No deviations occurred during this test run. The module was scrapped for safety reasons upon completion of the investigation and the customer has been provided a replacement. A review of the dhr did 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.
Patient Sequence No: 1, Text Type: N, H10
[83215595]
Livanova received a report that the s5 level sensor module did not display anything during priming. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2017-00645 |
| MDR Report Key | 6803564 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-18 |
| Date of Report | 2017-08-18 |
| Date of Event | 2017-06-22 |
| Date Mfgr Received | 2017-07-24 |
| Device Manufacturer Date | 2015-09-29 |
| Date Added to Maude | 2017-08-18 |
| 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 |
| 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 LEVEL SENSOR MODULE |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | DTW |
| Date Received | 2017-08-18 |
| Returned To Mfg | 2017-07-19 |
| Model Number | 23-40-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-08-18 |