Brand Name | LEVEL 1 HOTLINE FLUID WARMER, 390 |
Type of Device | WARMER, THERMAL, INFUSION FLUID |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan ln n |
minneapolis MN 55442 |
|
Manufacturer Contact |
reed
covert
|
6000 nathan lane north |
minneapolis, MN 55442
|
2247062300
|
|
MDR Report Key | 18951346 |
MDR Text Key | 338319647 |
Report Number | 3012307300-2024-01529 |
Device Sequence Number | 1 |
Product Code |
LGZ
|
UDI-Device Identifier | 10695085002796 |
UDI-Public | 10695085002796 |
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 |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/21/2024 |
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 |
Other
|
Device Model Number | HL-390 |
Device Catalogue Number | CON-HL-390 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/23/2024 |
Initial Date FDA Received | 03/21/2024 |
Supplement Dates Manufacturer Received | 04/25/2024
|
Supplement Dates FDA Received | 05/21/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/09/2023 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|