FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO 2
MDR report key: 3901732
·
Received May 5, 2014
Report
- Report Number
- 2242352-2014-00504
- Event Type
- Malfunction
- Date Received
- May 5, 2014
- Date of Event
- April 2, 2014
- Report Date
- April 8, 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
THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORT PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT THE VASOVIEW HEMOPRO 2 WOULD FIRE AND BURN WHEN THE BUTTON WAS NOT PRESSED. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268143 | VASOVIEW HEMOPRO 2 | ENDOSCOPIC VESSEL HARVESTING | GEI | MAQUET CARDIOVASCULAR, LLC | VH-4000 | 25089608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |