Brand Name | CLINITEK ATLAS - LONG DOOR |
Type of Device | CLINITEK ATLAS |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict avenue |
tarrytown NY 10591 |
|
Manufacturer (Section G) |
SPARTAN MEDICAL |
22740 lunn road |
|
cleveland OH 44149 |
|
Manufacturer Contact |
steven
andberg
|
2 edgewater drive |
norwood, MA 02062
|
7812693655
|
|
MDR Report Key | 7233920 |
MDR Text Key | 98984653 |
Report Number | 3002637618-2018-00012 |
Device Sequence Number | 1 |
Product Code |
KQO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K932674 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Service and Testing Personnel
|
Type of Report
| Initial |
Report Date |
02/01/2018 |
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 |
Service and Testing Personnel
|
Device Catalogue Number | 10317674 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/17/2018
|
Initial Date FDA Received | 02/01/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |