Brand Name | STRATUS CS STAT FLUOROMETRIC ANALYZER |
Type of Device | STRATUS CS |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
glasgow business community |
newark DE 19702 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS INC |
62 flandres-bartley rd. |
|
flanders NJ 07836 |
|
Manufacturer Contact |
steven
andberg
|
2 edgewater drive |
norwood, MA 02062
|
7812693655
|
|
MDR Report Key | 5846816 |
MDR Text Key | 52409674 |
Report Number | 1217157-2016-00082 |
Device Sequence Number | 1 |
Product Code |
JHX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K984067 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/04/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other Health Care Professional
|
Device Catalogue Number | 10453531 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/08/2016 |
Initial Date FDA Received | 08/04/2016 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |