Brand Name | SENSATION PLUS 7.5FR. 40CC IAB |
Type of Device | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
Manufacturer (Section D) |
DATASCOPE CORP. - FAIRFIELD |
15 law drive |
fairfield NJ |
|
Manufacturer (Section G) |
DATASCOPE CORP. - FAIRFIELD |
15 law drive |
|
fairfield NJ |
|
Manufacturer Contact |
brian
schaeffer
|
15 law drive |
fairfield, NJ
|
|
MDR Report Key | 18790587 |
MDR Text Key | 336356261 |
Report Number | 2248146-2024-00118 |
Device Sequence Number | 1 |
Product Code |
DSP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K122628 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/12/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/27/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 0684-00-0567 |
Device Lot Number | 3000320636 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/12/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 08/10/2023 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |