Brand Name | STATIC AND DYNAMIC COMPLIANCE |
Type of Device | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
Manufacturer (Section D) |
CAREFUSION, INC |
22745 savi ranch parkway |
yorba linda CA 92887 |
|
Manufacturer (Section G) |
CAREFUSION, INC |
1100 bird center dr. |
|
palm springs CA 92262 |
|
Manufacturer Contact |
kristin
graf
|
22745 savi ranch parkway |
yorba linda, CA 92887
|
|
MDR Report Key | 6661466 |
MDR Text Key | 78355340 |
Report Number | 2021710-2017-06170 |
Device Sequence Number | 1 |
Product Code |
BTY
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K981366 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
11/03/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/22/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | VMAX ENCORE 22D |
Device Catalogue Number | 777405-101 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/31/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2014 |
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 |