FDA Adverse Event
Malfunction
Summary report: N
MAQUET
MDR report key: 2468887
·
Received February 21, 2012
Report
- Report Number
- MW5024377
- Event Type
- Malfunction
- Date Received
- February 21, 2012
- Date of Event
- November 24, 2011
- Report Date
- February 21, 2012
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PHYSICIAN WAS PERFORMING AN URGENT MYOCARDIAL REVASCULARIZATION X5 WITH LIMA, LEFT SCV PA, RIGHT RADIAL ARTERIAL LINE, LEFT ENDOSCOPIC VEIN HARVEST - LEFT GREATER SAPHENOUS VEIN. THE VASOVIEW HEMOPRO2 CAUTERY WOULD NOT WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAQUET | VASOVIEW HEMOPRO2 | GEI | MAQUET CARDIOVASCULAR LLC | VH-4000 | 25043813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |