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 | 19106629 |
MDR Text Key | 340907637 |
Report Number | 2242352-2024-00375 |
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 |
User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/28/2024 |
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 | VH-4000 |
Device Catalogue Number | VH-4000 |
Device Lot Number | 3000371798 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/26/2024
|
Initial Date FDA Received | 04/15/2024 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/28/2024
|
Date Device Manufactured | 02/08/2024 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | UNKNOWN. |
|
|