Brand Name | CARDIOSAVE HYBRID, TYPE B PLUG |
Type of Device | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
Manufacturer (Section D) |
DATASCOPE CORP. - MAHWAH |
1300 macarthur blvd |
mahwah NJ |
|
Manufacturer (Section G) |
DATASCOPE CORP. - MAHWAH |
1300 macarthur blvd |
|
mahwah NJ |
|
Manufacturer Contact |
arelean
guzman
|
1300 macarthur blvd |
mahwah, NJ
|
|
MDR Report Key | 17745103 |
MDR Text Key | 323396218 |
Report Number | 2249723-2023-04042 |
Device Sequence Number | 1 |
Product Code |
DSP
|
UDI-Device Identifier | 10607567108391 |
UDI-Public | 10607567108391 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K112372 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup,Followup |
Report Date |
12/12/2023 |
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 Operator |
Health Professional
|
Device Model Number | 0998-00-0800-53 |
Device Catalogue Number | 0998-00-0800-53 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/06/2023 |
Initial Date FDA Received | 09/14/2023 |
Supplement Dates Manufacturer Received | 09/15/2023 12/11/2023
|
Supplement Dates FDA Received | 09/19/2023 12/12/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/10/2015 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|