Brand Name | SOMATOM DEFINITION |
Type of Device | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
Manufacturer (Section D) |
SIEMENS HEALTHCARE GMBH CT |
medical solutions |
1 siemens strasse |
forchheim, 91301 |
GM 91301 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE GMBH CT |
medical solutions |
1 siemens strasse |
forchheim, 91301 |
GM
91301
|
|
Manufacturer Contact |
marlynne
galloway
|
40 liberty boulevard |
mail stop 65-1a |
malvern, PA 19355
|
6104486471
|
|
MDR Report Key | 6392733 |
MDR Text Key | 69512130 |
Report Number | 2240869-2017-01163 |
Device Sequence Number | 1 |
Product Code |
JAK
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K122471 |
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,Followup |
Report Date |
02/16/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/09/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 07740769 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 04/28/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/29/2010 |
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 | 59 YR |
|
|