MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2019-01-11 for MONACO manufactured by Elekta Inc.
[132993812]
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Patient Sequence No: 1, Text Type: N, H10
[132993813]
During elekta internal investigations it was found optimization parameters defaults values will not revert back to the original default values as set in the system but will "stick" to the values as defined by the user in the previous workflow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937649-2019-00001 |
| MDR Report Key | 8239343 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2019-01-11 |
| Date of Report | 2019-04-10 |
| Date Mfgr Received | 2018-12-14 |
| Date Added to Maude | 2019-01-11 |
| 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 FLEMMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Manufacturer G1 | ELEKTA INC. |
| Manufacturer Street | 400 PERIMETER CENTER TERRACE SUITE 50 |
| Manufacturer City | ATLANTA GA 30346 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30346 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONACO |
| Generic Name | SYSTEM, PLANNING, RADIATION THERAPY TREATMENT |
| Product Code | MUJ |
| Date Received | 2019-01-11 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INC |
| Manufacturer Address | 13723 RIVERPORT DRIVE SUITE 100 MARYLAND HEIGHTS MO 63043 US 63043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-11 |