FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO EVH SYSTEM
MDR report key: 2201490
·
Received August 4, 2011
Report
- Report Number
- 2242352-2011-01040
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- July 12, 2011
- Report Date
- July 12, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K101274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. ITEMS MARKED "NI" ARE UNKNOWN TO US AT THIS TIME. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO WAS NOT DELIVERING ANY ENERGY SO THEY SWAPPED OUT THE CABLE AND THE VH-3000 WORKED FINE. THERE WERE NO PATIENT EFFECTS. MAQUET CARDIOVASCULAR ANTICIPATES RETURN OF THE PRODUCT IN QUESTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW HEMOPRO EVH SYSTEM | DC EXTENSION CABLE | GEI | MAQUET CARDIOVASCULAR, LLC | VH-3030 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |