Brand Name | CAPNOCHECK II HANDHELD CAPNOGRAPH/OXIMETER |
Type of Device | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
|
minneapolis MN 55442 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 9295644 |
MDR Text Key | 165607513 |
Report Number | 3012307300-2019-06131 |
Device Sequence Number | 1 |
Product Code |
CCK
|
UDI-Device Identifier | 10610586036781 |
UDI-Public | 10610586036781 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K991086 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/08/2019 |
1 Device 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 | 8400 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/13/2019 |
Initial Date Manufacturer Received |
10/11/2019 |
Initial Date FDA Received | 11/08/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/12/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
|
|