Brand Name | INSPIRATORY/EXPIRATORY FILTER |
Type of Device | BREATHING CIRCUIT BACTERIAL FILTER |
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 |
omid
taheri
|
17400 laguna canyon road |
suite 300 |
irvine, CA 92618
|
8007923912
|
|
MDR Report Key | 18984195 |
MDR Text Key | 338673647 |
Report Number | 9611451-2024-00243 |
Device Sequence Number | 1 |
Product Code |
CAH
|
UDI-Device Identifier | 09420012432315 |
UDI-Public | (01)09420012432315(10)2102070685(11)220307 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K050927 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/26/2024 |
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 | RT019 |
Device Catalogue Number | RT019 |
Device Lot Number | 2102070685 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/20/2024 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/26/2024
|
Initial Date FDA Received | 03/26/2024 |
Supplement Dates Manufacturer Received | 04/02/2024
|
Supplement Dates FDA Received | 05/01/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/07/2022 |
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 |
Treatment | F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; SERVO-AIR VENTILATOR; SERVO-AIR VENTILATOR |