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 drive |
|
palm springs CA 92262 |
|
Manufacturer Contact |
jill
rittorno
|
22745 savi ranch parkway |
yorba linda, CA 92887
|
7149227830
|
|
MDR Report Key | 6028289 |
MDR Text Key | 57397600 |
Report Number | 2021710-2016-04637 |
Device Sequence Number | 1 |
Product Code |
BTY
|
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 |
Respiratory Therapist
|
Type of Report
| Initial |
Report Date |
09/20/2016 |
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 | VMAX ENCORE 29 UNIT ASSEMBLY |
Device Catalogue Number | 777497 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/20/2016
|
Initial Date FDA Received | 10/13/2016 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/02/2009 |
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 |
Treatment | CARDIO V6.51 CAM14 W/USB, (B)(4) |
Patient Outcome(s) |
Other;
|