Brand Name | STATIC AND DYNAMIC COMPLIANCE |
Type of Device | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
Manufacturer (Section D) |
CAREFUSION |
22745 savi ranch parkway |
yorba linda CA 92887 |
|
Manufacturer (Section G) |
CAREFUSION |
1100 bird center drive |
|
palm springs CA 92262 |
|
Manufacturer Contact |
jill
rittorno
|
75 north fairway drive |
vernon hills, IL 60061
|
8473628056
|
|
MDR Report Key | 5428594 |
MDR Text Key | 38159694 |
Report Number | 2021710-2016-03146 |
Device Sequence Number | 1 |
Product Code |
BTY
|
Combination Product (y/n) | N |
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 |
02/17/2014 |
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 | 22 E |
Device Catalogue Number | 777543-102 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/17/2014 |
Initial Date FDA Received | 02/10/2016 |
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 |