Brand Name | BCI |
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) |
NULL |
1265 grey fox rd. |
|
st. paul MN 55112 |
|
Manufacturer Contact |
david
halverson
|
6000 nathan lane north |
receiving dock |
minneapolis, MN 55442
|
|
MDR Report Key | 12715966 |
MDR Text Key | 279043520 |
Report Number | 3012307300-2021-10430 |
Device Sequence Number | 1 |
Product Code |
CCK
|
UDI-Device Identifier | 10610586036354 |
UDI-Public | 10610586036354 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup,Followup |
Report Date |
05/07/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/28/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 8400 |
Device Catalogue Number | 8400 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/04/2021 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 05/02/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/06/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|