MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-07 for PROTEUSONE PROTEUS 235 manufactured by Ion Beam Applications.
[72667301]
Evaluation summary: by using the following workflow, iba has been able to reproduce the issue: 1. Irradiation abort occurs, 2. User inputs delivered dose manually in the oncology information system and selects the aborted beam, 3. User selects the delivered dose from the oncology information system in the "partial report" dialog box in the "beam selection" screen, 4. User goes to "irradiation preparation" screen and then goes back to "beam selection" screen, 5. User cancels and reselects the aborted beam, 6. The "next" button is enabled in the "beam selection" screen and user is able to start irradiation without having to select the delivered dose in the "partial report" dialog box.. In step 6, the correct behavior of the system should be: the "next" button is disabled in the "beam selection" screen and user has to select the delivered dose in "partial report" dialog box.. Note that the "partial report" dialog box is a popup window which is shown in the center of "beam selection" screen when clicking on "partial" button in the "beam selection" screen.
Patient Sequence No: 1, Text Type: N, H10
[72667302]
Iba learned from a user that while a patient was being treated in pencil beam scanning treatment mode, irradiation was stopped and then the user was able to restart irradiation without having to select the correct partial irradiation data. The customer informed iba that the patient impacted by this malfunction received an over-dose of 38 mu (monitor units) for one fraction of his treatment. The over-dose due to that malfunction was +1. 8% of that fraction (38 mu/2068 mu). This represents about +0. 07% of total prescribed dose (25 fractions of treatment). There was no significant impact on patient treatment. Nevertheless, if the malfunction were to recur at the end of the irradiation, the whole dose of a fraction could be delivered twice, representing a potential over-dose of 1gy to 4gy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000256071-2017-00001 |
| MDR Report Key | 6471364 |
| Date Received | 2017-04-07 |
| Date of Report | 2017-02-17 |
| Date of Event | 2017-02-17 |
| Date Mfgr Received | 2017-02-17 |
| Device Manufacturer Date | 2014-09-02 |
| Date Added to Maude | 2017-04-07 |
| 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 | PHYSICIST |
| 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 |
| Manufacturer Phone | 10 203787 |
| 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 | 2017-04-07 |
| Model Number | PROTEUS 235 |
| Catalog Number | PROTEUS 235 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ION BEAM APPLICATIONS |
| Manufacturer Address | CHEMIN DU CYCLOTRON 3 LOUVAIN-LA-NEUVE, 1348 BE 1348 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-07 |