MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-03 for VOLUMEVIEW VLV8R520 manufactured by Edwards Lifesciences, Pr.
| Report Number | 2015691-2019-03288 |
| MDR Report Key | 8958094 |
| Date Received | 2019-09-03 |
| Date of Report | 2019-08-21 |
| Date of Event | 2019-08-15 |
| Date Mfgr Received | 2019-09-12 |
| Date Added to Maude | 2019-09-03 |
| 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 | MS. JESSICA ATALLAH |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492500294 |
| Manufacturer G1 | EDWARDS LIFESCIENCES, PR |
| Manufacturer Street | STATE RD INDUS PK 402 KM 1.4 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VOLUMEVIEW |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2019-09-03 |
| Returned To Mfg | 2019-09-05 |
| Model Number | VLV8R520 |
| Catalog Number | VLV8R520 |
| Lot Number | 61525341 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES, PR |
| Manufacturer Address | STATE RD INDUS PK 402 KM 1.4 ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-03 |