Brand Name | SYNCARDIA COMPANION 2 DRIVER |
Type of Device | EXTERNAL PNEUMATIC DRIVER |
Manufacturer (Section D) |
SYNCARDIA SYSTEMS, LLC |
1992 e silverlake road |
tucson AZ 85713 |
|
Manufacturer (Section G) |
SYNCARDIA SYSTEMS, LLC |
1992 e silverlake road |
|
tucson AZ 85713 |
|
Manufacturer Contact |
aaron
meier
|
1992 e silverlake road |
tucson, AZ 85713
|
5205451234
|
|
MDR Report Key | 18068104 |
MDR Text Key | 327374371 |
Report Number | 3003761017-2023-00150 |
Device Sequence Number | 1 |
Product Code |
LOZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P030011 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/26/2023 |
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 Catalogue Number | 397002-001 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/12/2023 |
Initial Date Manufacturer Received |
10/12/2023
|
Initial Date FDA Received | 11/03/2023 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|