| Brand Name | T.W. POWER SUPPLY |
| Common Device Name | UNIT, CAUTERY, THERMAL, AC-POWERED |
| Manufacturer (Section D) |
| MAQUET CARDIOVASCULAR LLC |
| 45 barbour pond drive |
| wayne NJ 07470 |
|
| Manufacturer (Section G) |
| MAQUET CARDIOVASCULAR LLC |
| 45 barbour pond drive |
|
| wayne NJ 07470 |
|
| Manufacturer Contact |
|
arelean
guzman
|
| 45 barbour pond drive |
| wayne, NJ 07470
|
|
| MDR Report Key | 25113138 |
| Report Number | 2242352-2026-0000332 |
| Device Sequence Number | 15757739 |
| Product Code |
HQO
|
| UDI-Device Identifier | 00607567700826 |
| UDI-Public | (01)00607567700826 |
| Combination Product (Y/N) | N |
| Initial Reporter State | GA |
| Initial Reporter Country | US |
| PMA/510(K) Number | K052274 |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Serviced by Third Party (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
Health Professional,User Facility,Company Representative |
| Initial Reporter Occupation |
Biomedical Engineer
|
| Type of Report
| Initial,Followup |
| Report Date (Section B) |
05/07/2026 |
| 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
|
| Operator of Device |
Health Professional
|
| Device Model Number | VH-3010 |
| Device Catalogue Number | VH-3010 |
| Was Device Available for Evaluation? |
No
|
| Is the Reporter a Health Professional? |
Yes
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 04/14/2026 |
| Supplement Date Received by Manufacturer | 05/25/2026
|
| Initial Report FDA Received Date | 05/07/2026 |
| Supplement Report FDA Received Date | 05/26/2026
|
| Was Device Evaluated by Manufacturer? (Y/N) |
No
|
| Is the Device Labeled for Single Use? (Y/N) |
No
|
| Usage of Device |
Reuse
|
| Patient Sequence Number | 1 |
Concomitant Medical Products and Therapy/Usage Dates | UNKNOWN. |
| Patient Sex | Unknown |
|
|