FDA Adverse Event
Injury
Summary report: N
MEVION S250
MDR report key: 6249580
·
Received January 13, 2017
Report
- Report Number
- 3007087027-2017-00004
- Event Type
- Injury
- Date Received
- January 13, 2017
- Date of Event
- August 23, 2016
- Report Date
- January 13, 2017
- Manufacturer
- MEVION MEDICAL SYSTEMS, INC.
- Product Code
- LHN
- UDI-DI
- 00864366000100
- PMA / PMN Number
- K120676
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32081 | MEVION S250 | MEVION S250 PROTON THERAPY SYSTEM | LHN | MEVION MEDICAL SYSTEMS, INC. | MEVION S250 | 00864366000100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |