Brand Name | S3 ROLLER PUMP |
Type of Device | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
LIVANOVA DEUTSCHLAND |
lindberghstr. 25 |
munich 80939 |
GM 80939 |
|
Manufacturer (Section G) |
LIVANOVA DEUTSCHLAND |
lindberghstr. 25 |
|
munich 80939 |
GM
80939
|
|
Manufacturer Contact |
joan
ceasar
|
14401 w. 65th way |
arvada, CO 80004
|
2822287260
|
|
MDR Report Key | 7138862 |
MDR Text Key | 95946831 |
Report Number | 9611109-2017-01039 |
Device Sequence Number | 1 |
Product Code |
DWB
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K950990 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
12/21/2017 |
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 |
Other
|
Device Model Number | 10-60-00 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/27/2017 |
Initial Date FDA Received | 12/21/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/06/2002 |
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 |