MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-09-28 for PROTEUSPLUS PROTEUS 235 manufactured by Iba (ion Beam Applications).
[87629689]
Use error, no malfunction of the device.
Patient Sequence No: 1, Text Type: N, H10
[87629690]
Iba has been made aware that for one beam of a particular fraction, a patient has been treated with an accessory in place whereas no accessory was prescribed. The therapist forgot to remove the accessory. The accessory was a range shifter of 7. 37 cm water equivalent thickness. As a consequence, the dose deposition has been shifted of 7. 37 cm in depth, leading to overdose in the proximal tissues and to underdose in the distal tissues. The attending physician assessed that it would not have an impact on the patient. There was no malfunction of iba medical device. This event is related to a use error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000256071-2017-00002 |
| MDR Report Key | 6900630 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-08-22 |
| Date Mfgr Received | 2017-08-30 |
| Device Manufacturer Date | 2010-01-31 |
| Date Added to Maude | 2017-09-28 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTEUSPLUS |
| Generic Name | PROTON THERAPY SYSTEM |
| Product Code | LHN |
| Date Received | 2017-09-28 |
| Model Number | PROTEUS 235 |
| Catalog Number | PROTEUS 235 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-09-28 |