MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-06-27 for EVEREST INFLATION DEVICE 30ATM AC3200 manufactured by Medtronic.
| Report Number | 1220452-2019-00080 |
| MDR Report Key | 8738396 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-06-27 |
| Date of Report | 2019-06-27 |
| Date of Event | 2019-06-06 |
| Date Mfgr Received | 2019-06-06 |
| Date Added to Maude | 2019-06-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | MEDTRONIC |
| Manufacturer City | DANVERS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVEREST INFLATION DEVICE 30ATM |
| Generic Name | ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS |
| Product Code | DTL |
| Date Received | 2019-06-27 |
| Catalog Number | AC3200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | DANVERS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-27 |