MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for ELEKTA UNITY manufactured by Elekta Ltd.
| Report Number | 9617016-2020-00001 |
| MDR Report Key | 9878524 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-25 |
| 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 | PMS |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Manufacturer G1 | ELEKTA LTD |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | RH10 9RR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEKTA UNITY |
| Generic Name | ACCELERATOR, LINEAR, MEDICAL |
| Product Code | IYE |
| Date Received | 2020-03-25 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA LTD |
| Manufacturer Address | LINAC HOUSE FLEMING WAY CRAWLEY, RH109RR UK RH10 9RR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |