MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for PROTEUSPLUS PROTEUS235 manufactured by Iba (ion Beam Applications).
[107728693]
On (b)(4) 2018, iba was made aware of a potential event in the clinical workflow of one customer in (b)(6), resulting in the correction vector not being applied before patient treatment. This event occurred after an upgrade of the hand pendant from wired to wireless at end of (b)(6) 2018. A number of patients has potentially received their treatment at a wrong position. The client and iba are currently investigating the possible impact on the treatment of each individual patient for the period in question. Since (b)(6) 2018, the client has adapted the clinical workflow to ensure that the correction vector is applied.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000256071-2018-00001 |
| MDR Report Key | 7482297 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-04-19 |
| Date of Event | 2018-03-26 |
| Date Mfgr Received | 2018-04-19 |
| Device Manufacturer Date | 2018-04-19 |
| Date Added to Maude | 2018-05-03 |
| 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, 1348 |
| Manufacturer Country | BE |
| Manufacturer Postal | 1348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROTEUSPLUS |
| Generic Name | PROTON THERAPY SYSTEM |
| Product Code | LHN |
| Date Received | 2018-05-03 |
| Model Number | PROTEUS235 |
| Catalog Number | PROTEUS235 |
| 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 | 2018-05-03 |