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 2019-03-27 for MONACO manufactured by Elekta Inc..
[140146730]
The investigation was completed by conducting a thorough evaluation of the product and the reported information. The monitor units for one beam displayed incorrectly. This issue could not be reproduced by elekta or the customer when using the data provided by the customer. The customer will receive a warning to validate all plans for correctness and perform a secondary monitor unit check. In this specific case, the site detected the mu discrepancy in plan qa, however if these checks were not completed by the user mistreatment could occur.
Patient Sequence No: 1, Text Type: N, H10
[140146731]
The customer reported that they are seeing the mu discrepancy when using wedge and no wedge with fixed weight in the same plan.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937649-2019-00003 |
| MDR Report Key | 8456456 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-28 |
| Date Mfgr Received | 2019-02-26 |
| Date Added to Maude | 2019-03-27 |
| 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 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 | 2019-03-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-03-27 |