Brand Name | MOSAIQ |
Type of Device | ACCELERATOR, LINEAR, MEDICAL |
Manufacturer (Section D) |
IMPAC MEDICAL SYSTEMS, INC. |
100 mathilda place, 5th floor |
sunnyvale CA 94086 |
|
Manufacturer (Section G) |
IMPAC MEDICAL SYSTEMS, INC. |
13723 riverport drive |
suite 100 |
maryland heights MO 63043 |
|
Manufacturer Contact |
pms
|
linac house |
fleming way |
crawley, west sussex RH10 -9RR
|
UK
RH10 9RR
|
|
MDR Report Key | 6131248 |
MDR Text Key | 60993171 |
Report Number | 2950347-2016-00054 |
Device Sequence Number | 1 |
Product Code |
IYE
|
UDI-Device Identifier | 00858164002091 |
UDI-Public | 00858164002091 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K141572 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/29/2016 |
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
|
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
11/02/2016 |
Initial Date FDA Received | 11/29/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|