Brand Name | HEMOPRO POWER SUPPLY |
Type of Device | UNIT, CAUTERY, THERMAL, AC-POWERED |
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 | 16239932 |
MDR Text Key | 308362130 |
Report Number | 2242352-2023-00060 |
Device Sequence Number | 1 |
Product Code |
HQO
|
UDI-Device Identifier | 00607567700826 |
UDI-Public | 00607567700826 |
Combination Product (y/n) | N |
PMA/PMN Number | K052274 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/14/2023 |
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 | C-VH-3010 |
Device Catalogue Number | C-VH-3010 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/29/2022
|
Initial Date FDA Received | 01/25/2023 |
Supplement Dates Manufacturer Received | 04/17/2023
|
Supplement Dates FDA Received | 04/17/2023
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/05/2017 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|