MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-15 for S5 GAS BLENDER SYSTEM 25-40-45 manufactured by Livanova Deutschland.
[145106571]
There was no patient involvement. Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). A livanova field service representative was dispatched to the facility to investigate. He tested the device and could reproduce the reported error message interrupting the connection to the gas supply. He re-connected the gas supply and the device was found to be working properly. The device has been requested back to the manufacturer site for further investigation. 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.
Patient Sequence No: 1, Text Type: N, H10
[145106572]
Livanova (b)(4) received a report of s5 gas blender system displaying an error message during priming. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2019-00348 |
| MDR Report Key | 8611433 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-15 |
| Date of Report | 2019-07-23 |
| Date Mfgr Received | 2019-06-26 |
| Device Manufacturer Date | 2011-04-29 |
| Date Added to Maude | 2019-05-15 |
| 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 | ARVAD CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| 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 GAS BLENDER SYSTEM |
| Generic Name | GAS CONTROL UNIT, CARDIOPULMONARY BYPASS |
| Product Code | DTX |
| Date Received | 2019-05-15 |
| Model Number | 25-40-45 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA DEUTSCHLAND |
| Manufacturer Address | LINDBERGHSTR. 25 MUNICH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-15 |