MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-23 for PROTEUSONE PROTEUS 235 manufactured by Iba (ion Beam Applications).
[129332070]
The event occurred because of the failure of rod end bearings (ball joint heads). The broken ball joint heads were immediately replaced on site.
Patient Sequence No: 1, Text Type: N, H10
[129332071]
The proteusone treatment rooms are equipped with a gantry rolling floor that enables the clinician to enter the patient enclosure to help patient positioning on the couch. This rolling floor is moving in conjunction with the gantry. During cone beam computed tomography acquisition, the gantry rolling floor detached from the nozzle. As a consequence, the gantry rolling floor slipped under its own weight through the rail. No one was standing on the gantry rolling floor during the gantry rotation as specified in the clinical user guide. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000256071-2018-00004 |
| MDR Report Key | 8099710 |
| Date Received | 2018-11-23 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-11-16 |
| Date Added to Maude | 2018-11-23 |
| 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 | MS. SYLVIANE BERGER |
| Manufacturer Street | CHEMIN DU CYCLOTRON 3 |
| Manufacturer City | LOUVAIN-LA-NEUVE, |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROTEUSONE |
| Generic Name | PROTON THERAPY SYSTEM |
| Product Code | LHN |
| Date Received | 2018-11-23 |
| Model Number | PROTEUS 235 |
| Catalog Number | PROTEUS 235 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-11-23 |