MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-22 for MRIDIAN SYSTEMS 20000, 10000 manufactured by Viewray, Inc..
| Report Number | 3011233554-2019-00006 |
| MDR Report Key | 9363580 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-22 |
| Date of Report | 2019-11-22 |
| Date of Event | 2019-11-10 |
| Date Mfgr Received | 2019-11-10 |
| Date Added to Maude | 2019-11-22 |
| 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 | MR. SEAN DELANEY |
| Manufacturer Street | 815 E. MIDDLEFIELD RD |
| Manufacturer City | MOUNTAIN VIEW CA 94043 |
| Manufacturer Country | US |
| Manufacturer Postal | 94043 |
| Manufacturer Phone | 6502520920 |
| Manufacturer G1 | VIEWRAY, INC. |
| Manufacturer Street | 815 E. MIDDLEFIELD RD. |
| Manufacturer City | MOUNTAIN VIEW CA 94043 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94043 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MRIDIAN SYSTEMS |
| Generic Name | MRIDIAN SYSTEMS |
| Product Code | IYE |
| Date Received | 2019-11-22 |
| Model Number | 20000, 10000 |
| Catalog Number | 20000, 10000 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VIEWRAY, INC. |
| Manufacturer Address | 815 E. MIDDLEFIELD RD. MOUNTAIN VIEW CA 94043 US 94043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-22 |