Brand Name | BCI CAPNOCHECK II, MODEL 8400 |
Type of Device | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
Manufacturer (Section D) |
ST PAUL |
1265 grey fox rd. |
st. paul MN 55112 |
|
Manufacturer (Section G) |
ST PAUL |
1265 grey fox rd. |
|
st. paul MN 55112 |
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
minneapolis, MN 55442
|
|
MDR Report Key | 15328962 |
MDR Text Key | 302939404 |
Report Number | 3012307300-2022-17073 |
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 |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
08/31/2022 |
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 Model Number | 8401 |
Device Catalogue Number | 8401 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/15/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/23/2022 |
Initial Date FDA Received | 08/31/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/21/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |