Brand Name | CAREFUSION |
Type of Device | VENTILATOR, HIGH FREQUENCY |
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 n. fairway drive |
vernon hills, IL
|
8473628056
|
|
MDR Report Key | 5065451 |
MDR Text Key | 25429393 |
Report Number | 2021710-2015-01595 |
Device Sequence Number | 1 |
Product Code |
LSZ
|
Combination Product (y/n) | N |
PMA/PMN Number | P890057 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Health Professional
|
Report Date |
08/12/2015 |
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 | 3100B |
Device Catalogue Number | 773967 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/01/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 09/09/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/01/2009 |
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 |