MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for CENTRIFUGAL PUMP 5 (CP5) 60-02-60 manufactured by Livanova Deutschland Gmbh.
| Report Number | 1718850-2020-01044 |
| MDR Report Key | 9856366 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Facility Aware | 2020-02-19 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRIFUGAL PUMP 5 (CP5) |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
| Product Code | DWA |
| Date Received | 2020-03-19 |
| Model Number | 60-02-60 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-19 |