MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2018-07-05 for MONACO manufactured by Elekta Inc.
[113181417]
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
[113181418]
The customer reported an issue with the bolus dose calculation in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937649-2018-00017 |
| MDR Report Key | 7663107 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2018-07-05 |
| Date of Report | 2018-08-10 |
| Date Mfgr Received | 2018-06-06 |
| Date Added to Maude | 2018-07-05 |
| 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 | PHYSICIST |
| 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 | 2018-07-05 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-07-05 |