Brand Name | CARTRIDGES, W/ 3" EXT SET, ENFLOW, 30/CS |
Type of Device | WARMER, THERMAL, INFUSION FLUID |
Manufacturer (Section D) |
CAREFUSION, INC |
22745 savi ranch parkway |
yorba linda CA 92887 |
|
Manufacturer (Section G) |
HEALTHCARE TECHNOLOGY INTL LTD |
yin yang industrial estate, zh |
|
dongguan 53262 0 |
CH
532620
|
|
Manufacturer Contact |
jill
rittorno
|
22745 savi ranch parkway |
yorba linda, CA 92887
|
|
MDR Report Key | 6281248 |
MDR Text Key | 65895670 |
Report Number | 2050001-2017-00045 |
Device Sequence Number | 1 |
Product Code |
LGZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130867 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
01/26/2017 |
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 |
Health Professional
|
Device Catalogue Number | 980202EU |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/13/2017 |
Initial Date FDA Received | 01/26/2017 |
Was Device Evaluated by Manufacturer? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|