MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for PROTEUSONE PROTEUS 235 manufactured by Iba (ion Beam Applications).
[131931391]
Event analysis showed that when restarting the power supply, the current of the magnets increased directly to its setpoint, without cycling. Software code review showed that this cycling is not performed if during an treatment field, the "set range" is not successfully completed for any reason (manual pause, device error, magnet issue, etc. ) and a magnet power supply current drops below the requested current (e. G. If the power supply is re-booted). As a consequence, the beam characteristics could be wrong when starting irradiation after resuming the treatment field. As there is a cycling of the magnets before each treatment beam, the issue will impact only one treatment field.
Patient Sequence No: 1, Text Type: N, H10
[131931392]
During a routine quality assurance inspection, one of the magnets of the proton beam line failed. The user paused the beam and iba site team power cycled the power supplies of all the magnets. The user then observed a range error of 2mm compared to the expected range. No error message was provided by the proton therapy system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000256071-2018-00006 |
| MDR Report Key | 8188884 |
| Date Received | 2018-12-21 |
| Date of Report | 2018-11-22 |
| Date of Event | 2018-11-22 |
| Date Mfgr Received | 2018-11-22 |
| Device Manufacturer Date | 2018-05-02 |
| Date Added to Maude | 2018-12-21 |
| 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 | MS. SYLVIANE |
| Manufacturer Street | CHEMIN DU CYCLOTRON 3 |
| Manufacturer City | LOUVAIN-LA-NEUVE, 1348 |
| Manufacturer Country | BE |
| Manufacturer Postal | 1348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROTEUSONE |
| Generic Name | PROTEUSONE |
| Product Code | LHN |
| Date Received | 2018-12-21 |
| Model Number | PROTEUS 235 |
| Catalog Number | PROTEUS 235 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IBA (ION BEAM APPLICATIONS) |
| Manufacturer Address | CHEMIN DU CYCLOTRON 3 LOUVAIN-LA-NEUVE, 1348 BE 1348 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-21 |