Brand Name | SOMATOM DEFINITION AS |
Type of Device | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
Manufacturer (Section D) |
SIEMENS HEALTHINEERS GMBH |
advanced therapy |
siemenstrasse 1 |
forchheim, 91301 |
GM 91301 |
|
Manufacturer (Section G) |
SIEMENS HEALTHINEERS GMBH |
advanced therapy |
siemenstrasse 1 |
forchheim, 91301 |
GM
91301
|
|
Manufacturer Contact |
mary
stamer
|
40 liberty boulevard |
ms-65-1a |
malvern, PA 19355-9998
|
6104486485
|
|
MDR Report Key | 7455641 |
MDR Text Key | 106341974 |
Report Number | 3004977335-2018-23436 |
Device Sequence Number | 1 |
Product Code |
JAK
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K103127 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Remedial Action |
Patient Monitoring |
Type of Report
| Initial |
Report Date |
04/24/2018,04/23/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/24/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 8098027 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/24/2018 |
Device Age | 2 YR |
Event Location |
Outpatient Diagnostic Facility
|
Date Report to Manufacturer | 03/27/2018 |
Date Manufacturer Received | 03/27/2018 |
Date Device Manufactured | 12/08/2015 |
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) |
Required Intervention;
|
|
|