Brand Name | AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA |
Type of Device | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
PERFUSION SYSTEMS |
7611 northland dr |
brooklyn park MN 55428 |
|
Manufacturer (Section G) |
PERFUSION SYSTEMS |
7611 northland dr |
|
brooklyn park MN 55428 |
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea street ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 7831998 |
MDR Text Key | 118883248 |
Report Number | 2184009-2018-00027 |
Device Sequence Number | 1 |
Product Code |
DWF
|
UDI-Device Identifier | 20613994495505 |
UDI-Public | 20613994495505 |
Combination Product (y/n) | N |
Reporter Country Code | TW |
PMA/PMN Number | K810548 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician Assistant
|
Type of Report
| Initial |
Report Date |
08/30/2018 |
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 Expiration Date | 09/30/2020 |
Device Model Number | 20012 |
Device Catalogue Number | 20012 |
Device Lot Number | 2017090539 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/21/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/06/2018 |
Initial Date FDA Received | 08/30/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/09/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |