Brand Name | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION |
Type of Device | VENTILATOR, NON-CONTINUOUS |
Manufacturer (Section D) |
CAREFUSION |
yorba linda CA |
|
Manufacturer (Section G) |
CAREFUSION |
1100 bird center dr. |
|
palm springs CA 92262 |
|
Manufacturer Contact |
jill
rittorno
|
22745 savi ranch parkway |
yorba linda, CA 92887
|
7607787219
|
|
MDR Report Key | 4548186 |
MDR Text Key | 5511476 |
Report Number | 2021710-2015-00338 |
Device Sequence Number | 1 |
Product Code |
BZD
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K031745 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor,distributor,foreign |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup |
Report Date |
01/20/2015 |
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 | SIPAP |
Device Catalogue Number | 675-CFG-012 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/22/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/20/2015
|
Initial Date FDA Received | 02/19/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 01/05/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/01/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|