Brand Name | AVEA VENTILATOR |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
VYAIRE MEDICAL, INC |
22745 savi ranch parkway |
yorba linda CA 92887 |
|
Manufacturer (Section G) |
VYAIRE MEDICAL, INC |
1100 bird center dr. |
|
palm springs CA 92262 |
|
Manufacturer Contact |
kristin
graf
|
22745 savi ranch parkway |
yorba linda, CA 92887
|
|
MDR Report Key | 6818948 |
MDR Text Key | 83602384 |
Report Number | 2021710-2017-06522 |
Device Sequence Number | 1 |
Product Code |
CBK
|
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 faci |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
08/24/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | AVEA COMP |
Device Catalogue Number | 17310-00 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/27/2017 |
Initial Date FDA Received | 08/24/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/01/2017 |
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|