MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-08-30 for TOMOTHERAPY H SERIES 1018284 manufactured by Accuray Incorporated.
| Report Number | 3003873069-2019-00010 |
| MDR Report Key | 8951883 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-08-30 |
| Date of Report | 2019-08-30 |
| Date of Event | 2019-08-15 |
| Date Mfgr Received | 2019-08-15 |
| Device Manufacturer Date | 2014-06-26 |
| Date Added to Maude | 2019-08-30 |
| 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 | MR. DANIEL BIANK |
| Manufacturer Street | 1240 DEMING WAY |
| Manufacturer City | MADISON WI 53717 |
| Manufacturer Country | US |
| Manufacturer Postal | 53717 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOMOTHERAPY H SERIES |
| Generic Name | TOMOTHERAPY TREATMENT SYSTEM |
| Product Code | IYE |
| Date Received | 2019-08-30 |
| Model Number | 1018284 |
| Catalog Number | 1018284 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCURAY INCORPORATED |
| Manufacturer Address | 1240 DEMING WAY MADISON WI 53717 US 53717 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-30 |