Brand Name | LEVEL 1 FAST FLOW FLUID WARMER |
Type of Device | WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION |
Manufacturer (Section D) |
OAKDALE |
3350 granada ave n |
oakdale MN 55128 |
|
Manufacturer (Section G) |
OAKDALE |
3350 granada ave n |
|
oakdale MN 55128 |
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
minneapolis, MN 55442
|
|
MDR Report Key | 15639719 |
MDR Text Key | 306628918 |
Report Number | 3012307300-2022-25415 |
Device Sequence Number | 1 |
Product Code |
BSB
|
UDI-Device Identifier | 50695085829506 |
UDI-Public | 50695085829506 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | BK940056 |
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 |
10/20/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/20/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 8002950 |
Device Catalogue Number | 8002950 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/19/2019 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 09/23/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/10/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |