Brand Name | AIRVO 2 HUMIDIFIER |
Type of Device | AIRVO 2 HUMIDIFIER |
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 | 14639014 |
MDR Text Key | 295615020 |
Report Number | 9611451-2022-00528 |
Device Sequence Number | 1 |
Product Code |
BTT
|
UDI-Device Identifier | 09420012422347 |
UDI-Public | (01)09420012422347(10)2100414364(11)180213 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K131895 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
05/16/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/08/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | PT101 |
Device Catalogue Number | PT101 |
Device Lot Number | 2100414364 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/16/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/13/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |