FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW 7 XB
MDR report key: 4870888
·
Received June 23, 2015
Report
- Report Number
- 2242352-2015-00513
- Event Type
- Malfunction
- Date Received
- June 23, 2015
- Report Date
- May 28, 2015
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K041981
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
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. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOTS 25108053, 25113704, AND 25111149; THE LAST LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE EVENT DATE. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEW 7 XB DEVICE HAD LOTS OF SMOKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406413 | VASOVIEW 7 XB | ENDOSCOPIC VESSEL HARVESTING | GEI | MAQUET CARDIOVASCULAR, LLC | C-VH-3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |