Brand Name | LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE |
Type of Device | SYSTEM, THERMAL REGULATING |
Manufacturer (Section D) |
SMITHS MEDICAL ASD; INC. |
6000 nathan lane n |
minneapolis, MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD; INC. |
6000 nathan lane n |
|
minneapolis, MN 55442 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane n |
minneapolis,, MN 55442
|
7633833310
|
|
MDR Report Key | 8689351 |
MDR Text Key | 147737355 |
Report Number | 3012307300-2019-03212 |
Device Sequence Number | 1 |
Product Code |
DWJ
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K141686 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
Report Date |
07/10/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 04/23/2021 |
Device Catalogue Number | SWU-2001 |
Device Lot Number | 3635259 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/20/2019 |
Initial Date FDA Received | 06/11/2019 |
Supplement Dates Manufacturer Received | 06/12/2019
|
Supplement Dates FDA Received | 07/10/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/10/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|