MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-30 for S5 DOUBLE HEAD PUMP 10-85-00 manufactured by Livanova Deutschland Gmbh.
[176949742]
There was no patient involvement. (b)(4). A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue. He traced the failure back to the inverter board of the touchscreen, in particular to the coil. Since this type of board is obsolete, the technician replaced the touchscreen and the associated parts. The issue was solved. Subsequent functional verification testing was completed without further issues and the unit was returned to service.
Patient Sequence No: 1, Text Type: N, H10
[176949743]
Livanova (b)(4) received a report that during setup a s5 system alarmed. The s5 double head pump was restarted and smoke came out of the device. The pump was swapped with another. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2020-00041 |
| MDR Report Key | 9646573 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2008-02-21 |
| Date Added to Maude | 2020-01-30 |
| 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 DOUBLE HEAD PUMP |
| Generic Name | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
| Product Code | DWB |
| Date Received | 2020-01-30 |
| Model Number | 10-85-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA DEUTSCHLAND GMBH |
| Manufacturer Address | LINDBERGHSTR. 25 MUNICH 80309 GM 80309 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-30 |