Brand Name | CENTRIMAG 2ND GENERATION PRIMARY CONSOLE |
Type of Device | Control, pump speed, cardiopulmonary bypass |
Manufacturer (Section D) |
THORATEC SWITZERLAND GMBH |
technoparkstrasse 1 |
zurich CH-80 05 |
SZ CH-8005 |
|
Manufacturer (Section G) |
THORATEC SWITZERLAND GMBH |
technoparkstrasse 1 |
|
zurich CH-80 05 |
SZ
CH-8005
|
|
Manufacturer Contact |
lindsey
sallese
|
6035 stoneridge drive |
pleasanton, CA 94588
|
7818528207
|
|
MDR Report Key | 18694029 |
MDR Text Key | 336068982 |
Report Number | 3003306248-2024-00031 |
Device Sequence Number | 1 |
Product Code |
DWA
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K131179 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
02/13/2024 |
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 |
Lay User/Patient
|
Device Model Number | 201-30300 |
Device Lot Number | L06935 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/24/2024
|
Initial Date FDA Received | 02/13/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/30/2020 |
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 |