Brand Name | MEVION S250I |
Type of Device | MEVION PROTON RADIATION THERAPY SYSTEM |
Manufacturer (Section D) |
MEVION MEDICAL SYSTEMS, INC. |
300 foster street, |
littleton MA 01460 |
|
Manufacturer (Section G) |
MEVION MEDICAL SYSTEMS, INC. |
300 foster st |
|
littleton MA 01460 |
|
Manufacturer Contact |
morris
bellows
|
300 foster st |
littleton, MA 01460
|
9785401500
|
|
MDR Report Key | 10719879 |
MDR Text Key | 241258934 |
Report Number | 3007087027-2020-00006 |
Device Sequence Number | 1 |
Product Code |
LHN
|
UDI-Device Identifier | 00864366000124 |
UDI-Public | (01)00864366000124(11)181219 |
Combination Product (y/n) | N |
Reporter Country Code | NL |
PMA/PMN Number | K172848 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Notification |
Type of Report
| Initial |
Report Date |
10/20/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | MEVION S250I |
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/24/2020 |
Initial Date FDA Received | 10/22/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/19/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|