Brand Name | MEVATRON PRIMUS (PRIMUS PLUS) |
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
|
4843234198
|
|
MDR Report Key | 8310045 |
MDR Text Key | 137374046 |
Report Number | 3002466018-2019-66402 |
Device Sequence Number | 1 |
Product Code |
IYE
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K982513 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/24/2019,08/10/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 4504200 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Event Location |
Hospital
|
Date Report to Manufacturer | 01/24/2019 |
Initial Date Manufacturer Received |
01/24/2019 |
Initial Date FDA Received | 02/06/2019 |
Supplement Dates Manufacturer Received | 08/09/2022
|
Supplement Dates FDA Received | 08/10/2022
|
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 |
Patient Outcome(s) |
Other;
|
Patient Age | 76 YR |
Patient Sex | Male |
Patient Weight | 72 KG |
|
|