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 | 18727597 |
MDR Text Key | 336628980 |
Report Number | 2242352-2024-00120 |
Device Sequence Number | 1 |
Product Code |
HQO
|
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 |
03/11/2024 |
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 | C--3010 |
Device Catalogue Number | C-VH-3010 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/23/2024
|
Initial Date FDA Received | 02/16/2024 |
Supplement Dates Manufacturer Received | 03/20/2024
|
Supplement Dates FDA Received | 03/20/2024
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|