Brand Name | SOMATOM EMOTION 16 |
Type of Device | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
Manufacturer (Section D) |
SIEMENS SHANGHAI MEDICAL EQUIPMENT, LTD. |
278 zhou zhou road |
shanghai, 20131 8 |
CH 201318 |
|
Manufacturer (Section G) |
SIEMENS SHANGHAI MEDICAL EQUIPMENT, LTD. |
278 zhou zhou road |
|
shanghai, 20131 8 |
CH
201318
|
|
Manufacturer Contact |
marlynne
galloway
|
40 liberty boulevard |
mc: 65-1a |
malvern, PA 19355-9998
|
6104486471
|
|
MDR Report Key | 7136072 |
MDR Text Key | 95451057 |
Report Number | 3003202425-2017-08267 |
Device Sequence Number | 1 |
Product Code |
JAK
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | K151752 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
12/20/2017,11/28/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/20/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 10165977 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/20/2017 |
Distributor Facility Aware Date | 11/28/2017 |
Device Age | 5 YR |
Event Location |
Hospital
|
Date Report to Manufacturer | 12/20/2017 |
Date Manufacturer Received | 11/28/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/02/2012 |
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 | 82 YR |
|
|