Brand Name | INFANT 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
|
17400 laguna canyon road |
suite #300 |
irvine, CA 92618
|
9494534000
|
|
MDR Report Key | 14403992 |
MDR Text Key | 295494067 |
Report Number | 9611451-2022-00459 |
Device Sequence Number | 1 |
Product Code |
BZE
|
UDI-Device Identifier | 09420012431103 |
UDI-Public | (01)09420012431103(10)2101864970(11)211026 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K103767 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/19/2022 |
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 | RT266 |
Device Catalogue Number | RT266 |
Device Lot Number | 2101864970 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/12/2022 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/19/2022 |
Initial Date FDA Received | 05/15/2022 |
Supplement Dates Manufacturer Received | 08/25/2022
|
Supplement Dates FDA Received | 09/11/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/26/2021 |
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 |
Treatment | PURITAN BENNETT 980 VENTILATOR; PURITAN BENNETT 980 VENTILATOR |