Brand Name | CLINITEK ADVANTUS |
Type of Device | CT ADVANTUS |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict avenue |
tarrytown 10591 |
|
Manufacturer (Section G) |
KIMBALL ELECRONICS |
ul. pozenanska 1/c |
poland sp.z o.o |
tarnowo podgorne, 62080 |
PL
62080
|
|
Manufacturer Contact |
steven
andberg
|
2 edgewater drive |
norwood, MA 02062
|
7812693655
|
|
MDR Report Key | 5486433 |
MDR Text Key | 40179294 |
Report Number | 1217157-2016-00025 |
Device Sequence Number | 1 |
Product Code |
KQO
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K063276 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Medical Technologist
|
Type of Report
| Initial |
Report Date |
03/08/2016 |
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 |
No Information
|
Device Catalogue Number | 10282611 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/12/2016 |
Initial Date FDA Received | 03/08/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|