Brand Name | VASOVIEW HEMOPRO 2 |
Type of Device | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Manufacturer (Section D) |
MAQUET CARDIOVASCULAR LLC |
45 barbour pond drive |
wayne NJ |
|
Manufacturer (Section G) |
MAQUET CARDIOVASCULAR LLC |
45 barbour pond drive |
|
wayne NJ |
|
Manufacturer Contact |
arelean
guzman
|
45 barbour pond drive |
wayne, NJ
|
|
MDR Report Key | 18954152 |
MDR Text Key | 338325057 |
Report Number | 2242352-2024-00281 |
Device Sequence Number | 1 |
Product Code |
GEI
|
UDI-Device Identifier | 00607567700406 |
UDI-Public | 00607567700406 |
Combination Product (y/n) | N |
PMA/PMN Number | K101274 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
03/21/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/21/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | VH-4000 |
Device Catalogue Number | VH-4000 |
Device Lot Number | 3000353455 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/08/2024 |
Date Manufacturer Received | 03/01/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/09/2023 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 68 YR |
Patient Sex | Male |