Brand Name | SOMATOM SENSATION 16 |
Type of Device | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
Manufacturer (Section D) |
SIEMENS HEALTHINEERS GMBH |
1 siemens strasse |
forchheim, 91301 |
GM 91301 |
|
Manufacturer (Section G) |
SIEMENS HEALTHINEERS GMBH |
1 siemens strasse |
|
forchheim, 91301 |
GM
91301
|
|
Manufacturer Contact |
marlynne
galloway
|
40 liberty boulevard |
mc: 65-1a |
malvern, PA 19355-9998
|
6104486471
|
|
MDR Report Key | 6855780 |
MDR Text Key | 85734759 |
Report Number | 3004977335-2017-04528 |
Device Sequence Number | 1 |
Product Code |
JAK
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K142955 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
09/08/2017,08/28/2017 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 07393114 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/08/2017 |
Distributor Facility Aware Date | 08/28/2017 |
Event Location |
Hospital
|
Date Report to Manufacturer | 09/08/2017 |
Initial Date Manufacturer Received |
08/28/2017 |
Initial Date FDA Received | 09/11/2017 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|