Brand Name | ADULT INSPIRATORY HEATED BREATHING CIRCUIT |
Type of Device | BTT |
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 | 16064918 |
MDR Text Key | 306430498 |
Report Number | 9611451-2022-01243 |
Device Sequence Number | 1 |
Product Code |
BTT
|
UDI-Device Identifier | 09420012430359 |
UDI-Public | (01)09420012430359(10)2102122047(11)220405 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | SEE H10 |
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 |
12/26/2022 |
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 | RT212 |
Device Catalogue Number | RT212 |
Device Lot Number | 2102122047 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/26/2022 |
Initial Date FDA Received | 12/28/2022 |
Supplement Dates Manufacturer Received | 01/30/2023
|
Supplement Dates FDA Received | 02/01/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/05/2022 |
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 |