MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-23 for MEVION S250 manufactured by .
[63617081]
Device was not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[63617082]
This notification reports a malfunction and adverse event. A software error has been identified wherein patient position corrections are lost when using multiple setup field plans to treat at multiple isocenters in sequence resulting in lost deltas when closing a setup field. A software error or other user condition can occur in the few milliseconds after the first setup field is closed and before the information is communicated back to the record and verify system. One mistreatment occurred whereby a single treatment fraction was delivered approximately 3 cm from the target area. The single treatment was more than 2 cm from the prescribed field edge, thus meeting the definition of a "serious injury". The product software shall be updated to resolve the issue and prevent recurrence of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007087027-2016-00003 |
| MDR Report Key | 6202289 |
| Date Received | 2016-12-23 |
| Date of Report | 2016-12-23 |
| Date of Event | 2016-11-22 |
| Date Mfgr Received | 2016-11-23 |
| Device Manufacturer Date | 2015-05-26 |
| Date Added to Maude | 2016-12-23 |
| 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 | MR. THOMAS FARIS |
| Manufacturer Street | 300 FOSTER STREET |
| Manufacturer City | LITTLETON MA 01460 |
| Manufacturer Country | US |
| Manufacturer Postal | 01460 |
| Manufacturer Phone | 9785401500 |
| Manufacturer G1 | MEVION MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 300 FOSTER STREET |
| Manufacturer City | LITTLETON MA 01460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEVION S250 |
| Generic Name | PROTON THERAPY DEVICE |
| Product Code | LHN |
| Date Received | 2016-12-23 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-23 |