Brand Name | STATIC AND DYNAMIC COMPLIANCE |
Type of Device | CALCULATOR, PREDICATED VALUES, PULMONARY FUNCTION |
Manufacturer (Section D) |
VYAIRE MEDICAL |
22745 savi ranch pkwy |
yorba linda CA 92887 |
|
Manufacturer (Section G) |
VYAIRE MEDICAL INC. |
1100 bird center drive |
|
palm springs CA 92262 |
|
Manufacturer Contact |
stanley
tan
|
22745 savi ranch pkwy |
yorba linda, CA 92887
|
7149193324
|
|
MDR Report Key | 8345688 |
MDR Text Key | 136526756 |
Report Number | 2021710-2019-09890 |
Device Sequence Number | 1 |
Product Code |
BTY
|
UDI-Device Identifier | 10846446021394 |
UDI-Public | (01)10846446021394 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K981366 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/07/2019 |
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 | PHYSICIAN CHOICE ENCORE TOWER |
Device Catalogue Number | 777543-102 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/19/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/31/2019
|
Initial Date FDA Received | 02/15/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/22/2010 |
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 |