MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-19 for PROTEUSPLUS PROTEUS 235 manufactured by Iba (ion Beam Applications).
[90652519]
Evaluation summary is provided.
Patient Sequence No: 1, Text Type: N, H10
[90652520]
Description of the event: iba has been informed that, on (b)(6) 2017, during a patient treatment, the range shifter was not correctly aligned on the rails. A range shifter is used in pencil beam scanning to shift the dose distribution in the targeted area in the patient. Treatment fields were delivered with a slightly angled range shifter. After the delivery of the treatment, while the gantry was at 340? , the patient hit the range shifter while getting sitted. The range shifter (23 pounds) then fell out and grazed the patient face. Impact of the event on the patient: the patient was sent to the emergency department of the hospital for evaluation. The patient was released with no injuries. The hospital evaluated the impact of the slightly angled range shifter on beam properties in treatment field to less than 1 mm in water-equivalent-thickness change for the treatment field, therefore well within their margin used in treatment planning. Iba is proactively reporting this event due to the heavy weight of the range shifter and significant impact it could have if there was a new occurrence. Evaluation summary: investigation demonstrated that the range shifter can be inserted with only the upper rail in the guide, the lower rail resting just outside the guide (see attachment). With this configuration, the locking pin will lock the range shifter into place and the insertion pins will also be pushed in (see attachments). However, with minimal outward pressure, the range shifter can be pulled out of the holder and fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000256071-2017-00003 |
| MDR Report Key | 6961204 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-19 |
| Date of Report | 2017-09-27 |
| Date of Event | 2017-09-27 |
| Date Mfgr Received | 2017-09-27 |
| Device Manufacturer Date | 2010-01-31 |
| Date Added to Maude | 2017-10-19 |
| 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 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTEUSPLUS |
| Generic Name | PROTON THERAPY SYSTEM |
| Product Code | LHN |
| Date Received | 2017-10-19 |
| 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 | 2017-10-19 |