Brand Name | LEVEL 1® HOTLINE® BLOOD AND FLUID WARMER |
Type of Device | WARMER, THERMAL, INFUSION FLUID |
Manufacturer (Section D) |
SMITHS MEDICAL, ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
1265 gray fox road |
|
st. paul MN 55112 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathane lane north |
plymouth, MN 55442
|
7633833310
|
|
MDR Report Key | 7005801 |
MDR Text Key | 91539558 |
Report Number | 3012307300-2017-02385 |
Device Sequence Number | 1 |
Product Code |
LGZ
|
UDI-Device Identifier | 50695085820909 |
UDI-Public | 50695085820909 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K911383 |
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 |
Report Date |
12/08/2017 |
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 Model Number | HL-10 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/02/2017 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/25/2017 |
Initial Date FDA Received | 11/07/2017 |
Supplement Dates Manufacturer Received | 11/15/2017
|
Supplement Dates FDA Received | 12/08/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/10/2017 |
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 |
|
|