MAUDE MDR 9391796
- MDR report key
- 9391796
- Report number
- 9391796
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-03-08
- Date received
- 2019-11-29
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | SORIN 3T HEATER-COOLER SYSTEM | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS | LIVANOVA DEUTSCHLAND GMBH | DWC | | | | | | | *
| * |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2019-11-29 | 0 |
|
Event Narratives#
No narrative records found.