Brand Name | P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER |
Type of Device | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
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 | 6880851 |
MDR Text Key | 87388326 |
Report Number | 2021710-2017-06643 |
Device Sequence Number | 1 |
Product Code |
BZR
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K883038 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
09/15/2017 |
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 | MICROBLENDER |
Device Catalogue Number | 10424 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/28/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/18/2017
|
Initial Date FDA Received | 09/20/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/01/2001 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |