Brand Name | CARDIOSAVE HYBRID TYPE I (AU) |
Type of Device | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
Manufacturer (Section D) |
DATASCOPE CORP. |
1300 macarthur blvd |
mahwah NJ 07430 |
|
Manufacturer (Section G) |
DATASCOPE CORP. |
1300 macarthur blvd |
|
mahwah NJ 07430 |
|
Manufacturer Contact |
arelean
guzman
|
1300 macarthur blvd |
mahwah, NJ 07430
|
|
MDR Report Key | 18334832 |
MDR Text Key | 330599196 |
Report Number | 2249723-2023-05293 |
Device Sequence Number | 1 |
Product Code |
DSP
|
UDI-Device Identifier | 10607567109053 |
UDI-Public | (01)10607567109053(21)CB351297D2 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K112372 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup,Followup |
Report Date |
09/25/2024 |
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 |
Health Professional
|
Device Model Number | 0998-00-0800-31 |
Device Catalogue Number | 0998-00-0800-31 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/05/2023 |
Initial Date FDA Received | 12/15/2023 |
Supplement Dates Manufacturer Received | 05/14/2024 09/25/2024
|
Supplement Dates FDA Received | 05/15/2024 10/02/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/12/2022 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |