Brand Name | BCI SPECTRO2 10 PULSE OXIMETER |
Type of Device | OXIMETER |
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 |
general receiving |
minneapolis, MN 55442
|
|
MDR Report Key | 13603475 |
MDR Text Key | 286247333 |
Report Number | 3012307300-2022-04170 |
Device Sequence Number | 1 |
Product Code |
DQA
|
UDI-Device Identifier | 30843418000016 |
UDI-Public | 30843418000016 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K083787 |
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 |
02/25/2022 |
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 | WW1000EN |
Device Catalogue Number | WW1000EN |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/28/2022 |
Initial Date FDA Received | 02/25/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/29/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |