Brand Name | LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE |
Type of Device | SYSTEM, THERMAL REGULATING |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD INC. |
1265 grey fox road |
|
st. paul MN 55112 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 6831141 |
MDR Text Key | 83993688 |
Report Number | 3012307300-2017-01976 |
Device Sequence Number | 1 |
Product Code |
DWJ
|
UDI-Device Identifier | 50695085000653 |
UDI-Public | 50695085000653 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K011907 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,user faci |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/30/2017 |
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 Operator |
Health Professional
|
Device Catalogue Number | SW5-HOSE-7 |
Device Lot Number | N2067 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/14/2017 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/14/2017 |
Initial Date FDA Received | 08/30/2017 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/07/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Treatment | LEVEL 1® EQUATOR® CONVECTIVE WARMER; LEVEL 1® SNUGGLE WARM® BLANKET |