Brand Name | ARTISTE MV |
Type of Device | ACCELERATOR, LINEAR, MEDICAL |
Manufacturer (Section D) |
SIEMENS HEALTHCARE GMBH |
roentgenstrasse 19-21 |
kemnath, 95478 |
GM 95478 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE GMBH |
roentgenstrasse 19-21 |
|
kemnath, 95478 |
GM
95478
|
|
Manufacturer Contact |
rebecca
tudor
|
40 liberty blvd. |
65-1a |
malvern, PA 19355
|
6104486484
|
|
MDR Report Key | 10895185 |
MDR Text Key | 250100140 |
Report Number | 3002466018-2020-53143 |
Device Sequence Number | 1 |
Product Code |
IYE
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K142434 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/23/2020 |
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 | 8139789 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
10/28/2020 |
Initial Date FDA Received | 11/24/2020 |
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 |
|
|