MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2019-05-30 for MONACO Monaco manufactured by Elekta Inc..
[146507296]
The investigation was completed by conducting a thorough evaluation of the product and the reported information. The issue was determined to be a defect in the product. The investigation found that on the monaco beam spreadsheet, it is possible to set the field size for a beam to symmetric (for a 3d plan) when the beam model identifies the machine jaws as asymmetric. The dicom export will read the beam spreadsheet value (symmetric in this case). The importing system could set the asymmetric beams to symmetric based on this information. The incorrect field would be treated which could result in an overdose or underdose of the ptv and subsequent overdose or underdose of normal structures. Dose errors could be greater than 5%. The probability of this occurring is implausible. Qa checks by the user and clinical qa would be verifying that the fields planned/calculated on monaco were correctly transferred to mosaiq. The field sizes switching from asymmetric on monaco to symmetric in mosaiq would be obvious and should be noticed by the dosimetrist, physicist and radiation therapist. The customer is using an old version of mosaiq (software version 2. 50. 5. D7sp20) and with the defect identified the incorrect field would be treated which could lead to an overdose or underdose of the ptv and subsequent overdose or underdose of normal structures. It is unlikely that the site would provide the wrong machine data. If the wrong data is provided, elekta's beam modeling process should catch the error with data verification tests. In addition, the user should detect the error when they accept their beam model and run their on-site commissioning tests. Finally, when comparing treatment planning segments to r&v segments before treatment, the discrepancies should be very obvious. No patients were mistreated. The defect in monaco will be fixed in a future release and the mosaiq defect was fixed in 2. 63 beta 01 which was released 15th october 2015.
Patient Sequence No: 1, Text Type: N, H10
[146507297]
The customer reported that the asymmetric segmented fields from monaco are showing wrong jaw positions in mosaiq.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937649-2019-00005 |
| MDR Report Key | 8653947 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date Mfgr Received | 2019-05-02 |
| Date Added to Maude | 2019-05-30 |
| 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 | 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 | 2019-05-30 |
| Model Number | Monaco |
| 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 | 2019-05-30 |