Brand Name | HOTLINE BLOOD AND FLUID WARMER |
Type of Device | LGZ - WARMER, THERMAL, INFUSION FLUID |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC., |
rockland MA |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD,INC., |
160 weymouth st. |
|
rockland MA 02370 |
|
Manufacturer Contact |
michele
seliga
|
1265 grey fox rd. |
st. paul, MN 55112
|
6516287604
|
|
MDR Report Key | 4736771 |
MDR Text Key | 5823756 |
Report Number | 2183502-2015-00276 |
Device Sequence Number | 1 |
Product Code |
LGZ
|
Combination Product (y/n) | N |
PMA/PMN Number | K911383 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Type of Report
| Initial |
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 | HL-90 |
Was Device Available for Evaluation? |
No
|
Device Age | 4 YR |
Initial Date Manufacturer Received |
04/03/2015 |
Initial Date FDA Received | 04/23/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/21/2010 |
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 |
|
|