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 2018-05-22 for PROTEUSPLUS PROTEUS 235 manufactured by Iba (ion Beam Applications).
[108857583]
Remedial action: range shifter insertion process has been changed from a one therapist role to a two therapist role. After range shifter insertion, each therapist independently inspects visually and manually to confirm that the range shifter is in the proper placement.
Patient Sequence No: 1, Text Type: N, H10
[108857584]
Description of the event: iba has been informed that on (b)(6) 2018 during the patient alignment phase before treatment, the range shifter was not correctly aligned on the rails. While the gantry was being rotated to the position prescribed for treatment, the range shifter (23 pounds) became dislodged and fell on the head of the patient. Impact of the event on the patient: the patient was sent to the emergency department of the hospital for imaging and assessment for the head trauma. The patient developed a small abrasion with a significant underlying hematoma. The patient was admitted for observation for 24 hours. There was no evidence of skull or cervical-spine fracture; however, the head cup under the patient's head/neck was broken as a result of the blunt impact. The hematoma resolved over the next 3 days. Iba is not aware of any follow-up care required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000256071-2018-00003 |
| MDR Report Key | 7532659 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-03 |
| Date of Event | 2018-05-03 |
| Date Mfgr Received | 2018-05-25 |
| Device Manufacturer Date | 2010-01-31 |
| Date Added to Maude | 2018-05-22 |
| 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 | 2018-05-22 |
| 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. Hospitalization | 2018-05-22 |