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 2017-01-13 for MEVION S250 manufactured by Mevion Medical Systems, Inc..
[64779264]
During patient setup, a radiation therapist failed to note the distance between the treatment machine applicator (the delivery head of the treatment machine) and the treatment table and pinched her finger between the applicator and the treatment table. As the applicator approaches the treatment area, it enters a slow mode of movement to prevent injuries. The therapists are trained and warned in the instructions for use to carefully monitor applicator position when moving it into treatment location.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007087027-2017-00004 |
| MDR Report Key | 6249580 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-13 |
| Date of Report | 2017-01-13 |
| Date of Event | 2016-08-23 |
| Date Mfgr Received | 2017-01-05 |
| Device Manufacturer Date | 2015-05-26 |
| Date Added to Maude | 2017-01-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | MEVION S250 |
| Generic Name | MEVION S250 PROTON THERAPY SYSTEM |
| Product Code | LHN |
| Date Received | 2017-01-13 |
| Model Number | MEVION S250 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEVION MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 300 FOSTER STREET LITTLETON MA 01460 US 01460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-13 |