MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-09 for S5 GAS BLENDER SYSTEM 25-40-45 manufactured by Livanova Deutschland Gmbh.
[179415048]
There was no patient involvement. Date of event is unknown. This information will be provided in a supplemental report if made available. Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). Through follow-up communication livanova (b)(4) learned that the issue was not reproducible. The affected device has been requested back to the manufacturer site 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
[179415049]
Livanova (b)(4) received a report that an error code associated to a discrepancy between the effective gas output value and the set one was displayed on a s5 gas blender system during priming. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2020-00009 |
| MDR Report Key | 9568284 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-09 |
| Date of Report | 2020-02-25 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2008-01-14 |
| Date Added to Maude | 2020-01-09 |
| 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 GMBH |
| 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 | S5 GAS BLENDER SYSTEM |
| Generic Name | GAS CONTROL UNIT, CARDIOPULMONARY BYPASS |
| Product Code | DTX |
| Date Received | 2020-01-09 |
| Model Number | 25-40-45 |
| 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 GMBH |
| Manufacturer Address | LINDBERGHSTR. 25 MUNICH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-09 |