Brand Name | CLINITEK STATUS+ |
Type of Device | CT STATUS+ |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict avenue |
tarrytown 10591 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
northern road |
chilton industrial estate |
sudbury CO10 2XQ |
UK
CO10 2XQ
|
|
Manufacturer Contact |
steven
andberg
|
2 edgewater drive |
norwood, MA 02062
|
7812693655
|
|
MDR Report Key | 4102882 |
MDR Text Key | 4758773 |
Report Number | 1217157-2014-00132 |
Device Sequence Number | 1 |
Product Code |
JIL
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K091216 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Nurse
|
Remedial Action |
Other |
Type of Report
| Initial,Followup |
Report Date |
09/01/2014 |
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
|
Device Catalogue Number | 10379680 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/25/2014 |
Initial Date FDA Received | 09/19/2014 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 09/25/2014
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 1217157-09-22-2014-001-R |
Patient Sequence Number | 1 |
|
|