FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO 2
MDR report key: 21923310
·
Received April 28, 2025
Report
- Report Number
- 2242352-2025-0000500
- Event Type
- Malfunction
- Date Received
- April 28, 2025
- Date of Event
- March 18, 2025
- Report Date
- April 28, 2025
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- GEI
- UDI-DI
- 00607567700406
- PMA / PMN Number
- K101274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.
Additional Manufacturer Narrative · 0
COMPLAINT BEING CANCELLED, DUPLICATE OF MFG REPORT NUMBER 2242352-2025-0000430.
Description of Event or Problem · 0
THE HOSPITAL REPORTED THAT VASOVIEW HEMOPRO 2 LITTLE PLASTIC PIECE ON HEMOPRO WAS BROKEN, JUST OPENED A NEW ONE FOR THE PATIENT.
Description of Event or Problem · 0
COMPLAINT BEING CANCELLED, DUPLICATE OF MFG REPORT NUMBER 2242352-2025-0000430.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 503750 | VASOVIEW HEMOPRO 2 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MAQUET CARDIOVASCULAR LLC | VH-4000 | 3000456892 | 00607567700406 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |