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 2018-05-04 for PROTEUSPLUS PROTEUS 235 manufactured by Iba (ion Beam Applications).
[108001135]
Evaluation summary is provided in (describe event or problem).
Patient Sequence No: 1, Text Type: N, H10
[108001136]
Description of the event: on (b)(6) 2018, a patient unexpectedly received water on him while he was being aligned in the treatment room, with the gantry at 0? Angle (nozzle above the patient). Impact of the event on the patient: the patient was not injured. He was able to remove himself from the table with assistance from clinical staff who received water on them as well. The patient was exposed to the water for two minutes at most. He received general cooling water (not hot water) on his legs. The water did not hit the patient's face or any mucous. Evaluation summary: it is estimated that the general cooling tank lost a total of 95 gallons of water in this leak. Investigation showed that the water came from a cooling hose that became detached from the cooling block of a quadripole magnet used for pencil beam scanning treatment mode. The hose clamp that secures the cooling hose to the cooling block was too far up the nipple to properly bite down on the barb of the nipple to prevent the pressure of the general cooling circuit from dislodging the cooling hose from the block.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000256071-2018-00002 |
| MDR Report Key | 7487371 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-04 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-04-13 |
| Date Mfgr Received | 2018-04-13 |
| Device Manufacturer Date | 2014-03-24 |
| Date Added to Maude | 2018-05-04 |
| 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 |
| Manufacturer Phone | 10 203787 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTEUSPLUS |
| Generic Name | PROTON THERAPY SYSTEM |
| Product Code | LHN |
| Date Received | 2018-05-04 |
| 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 | 2018-05-04 |