MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-13 for RAYSTATION 6.0 manufactured by Raysearch Laboratories Ab (publ).
[114540691]
User reported a significant dose hotspot in the inferior corner of an off-axis field. The deviation was detected during treatment planning and had no impact on the patient. The root cause was that the off-axis beam profile correction in the beam model had very high values beyond 20 cm. Clinic had failed to validate the beam model for very large or off-axis fields. They received assistance in adjusting the beam model. This was abnormal use, using the system contrary to instructions. The responsibility of the user to validate the beam model for all clinical situations for which it is to be used is clearly stated in the ifu, giving field size and off-axis fields as explicit examples of what needs to be included. The clinic's responsibility to validate the beam model is also "common knowledge" and has not been disputed by the customers. However, since more than one clinic has been found to use similar, incorrect beam models, a fsn has been issued (similar incident previously reported in 3007774465-2018-00002).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007774465-2018-00004 |
| MDR Report Key | 7687591 |
| Date Received | 2018-07-13 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-04-25 |
| Device Manufacturer Date | 2016-12-14 |
| Date Added to Maude | 2018-07-13 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID HEDFORS |
| Manufacturer Street | PO BOX 3297 |
| Manufacturer City | STOCKHOLM, 10365 |
| Manufacturer Country | SW |
| Manufacturer Postal | 10365 |
| Manufacturer G1 | RAYSEARCH LABORATORIES AB (PUBL) |
| Manufacturer Street | SVEAVAGEN 44 |
| Manufacturer City | STOCKHOLM, 11134 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 11134 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RAYSTATION |
| Generic Name | RADIATION THERAPY TREATMENT PLANNING SYSTEM |
| Product Code | MUJ |
| Date Received | 2018-07-13 |
| Model Number | 6.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAYSEARCH LABORATORIES AB (PUBL) |
| Manufacturer Address | SVEAVAGEN 44 STOCKHOLM, 11134 SW 11134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-13 |