Brand Name | S5 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 |
barbara
galasso
|
14401 w. 65th way |
arvada, CO 80004
|
|
MDR Report Key | 8698687 |
MDR Text Key | 148015253 |
Report Number | 9611109-2019-00454 |
Device Sequence Number | 1 |
Product Code |
DWB
|
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | K071318 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
06/14/2019 |
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 | 10-80-00 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/08/2019 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/13/2019 |
Initial Date FDA Received | 06/14/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/07/2012 |
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 |