Brand Name | ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT |
Type of Device | BZE |
Manufacturer (Section D) |
FISHER & PAYKEL HEALTHCARE LTD |
15 maurice paykel place |
east tamaki |
auckland, 2013 |
NZ 2013 |
|
Manufacturer (Section G) |
FISHER & PAYKEL HEALTHCARE LTD |
15 maurice paykel place |
east tamaki |
auckland, 2013 |
NZ
2013
|
|
Manufacturer Contact |
faranak
gomarooni
|
173 technology drive |
suite 100 |
irvine, CA 92618
|
9494534000
|
|
MDR Report Key | 13058413 |
MDR Text Key | 284625870 |
Report Number | 9611451-2021-01484 |
Device Sequence Number | 1 |
Product Code |
BZE
|
UDI-Device Identifier | 09420012429728 |
UDI-Public | (01)09420012429728(10)2101569245(11)210324 |
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | K103767 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Distributor |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
12/14/2021 |
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 | RT380 |
Device Catalogue Number | RT380 |
Device Lot Number | 2101569245 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/14/2021 |
Initial Date FDA Received | 12/22/2021 |
Supplement Dates Manufacturer Received | 02/08/2022
|
Supplement Dates FDA Received | 02/24/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/24/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |