MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-10 for RAYSTATION 5 manufactured by Raysearch Laboratories Ab (publ).
[114009269]
A customer reported that a significant deviation in dose was found in plan qa for a dmlc plan. The problem was identified prior to treatment, so no patient was affected. Investigation showed a software error in the fluence calculation for dmlc "sliding window" plans with collimator angle other than zero, for beam models where the primary source is highly asymmetric. In the dmlc fluence calculation for "sliding window" type plans, there are x- and y-limits in the integration of the primary source. These limits were erroneously rotated with the collimator instead of being fixed relative to the gantry. There were tests in place for verifying fluence calculation for asymmetric source and collimator rotation. However, the error was significant only for highly asymmetric sources and the test used a "normal" source that was only mildly asymmetric, so the error was not detected. A field safety notice has been distributed to all affected users.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007774465-2018-00003 |
| MDR Report Key | 7672784 |
| Date Received | 2018-07-10 |
| Date of Report | 2018-07-10 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2016-04-20 |
| Date Added to Maude | 2018-07-10 |
| 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 | MS. VIKTORIA HAMMARSTEDT |
| Manufacturer Street | SVEAVAGEN 44 |
| Manufacturer City | STOCKHOLM, 11134 |
| Manufacturer Country | SW |
| Manufacturer Postal | 11134 |
| 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 | 2018-07-10 |
| Model Number | 5 |
| 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 | 2018-07-10 |