FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO 2
MDR report key: 3770381
·
Received February 18, 2014
Report
- Report Number
- 2242352-2014-00125
- Event Type
- Malfunction
- Date Received
- February 18, 2014
- Report Date
- January 24, 2014
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K101274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVAL CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT THE BALLOON ON THE BTT SHORT ON THE VASOVIEW HEMOPRO 2 DEFLATED. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102594 | VASOVIEW HEMOPRO 2 | ENDOSCOPIC VESSEL HARVESTING | GEI | MAQUET CARDIOVASCULAR, LLC | VH-4000 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |