Brand Name | AVEA VENTILATOR |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
VYAIRE MEDICAL INC. |
26125 n. riverwoods blvd. |
mettawa IL 60045 |
|
Manufacturer (Section G) |
VYAIRE MEDICAL INC. |
1100 bird center drive |
|
palm springs CA 92262 |
|
Manufacturer Contact |
erika
bonilla
|
510 technology dr |
irvine, IL 92618
|
7149227837
|
|
MDR Report Key | 12756198 |
MDR Text Key | 280532702 |
Report Number | 2021710-2021-14793 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 10846446066074 |
UDI-Public | (01)10846446066074(11)20200530 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K103211 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/08/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/07/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | AVEA |
Device Catalogue Number | 32029-001 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/08/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/30/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |