FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO EVH SYSTEM
MDR report key: 2192910
·
Received July 25, 2011
Report
- Report Number
- 2242352-2011-00998
- Event Type
- Malfunction
- Date Received
- July 25, 2011
- Date of Event
- June 30, 2011
- Report Date
- July 1, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC.
- Product Code
- GEI
- PMA / PMN Number
- K052274
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. THE LOT NUMBER COULD NOT BE OBTAINED SO A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO CONTINUED TO ACTIVATE AFTER THEY LET GO OF THE TOGGLE SWITCH. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT IS NOT RETURNING. THE LOT NUMBER IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW HEMOPRO EVH SYSTEM | ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | MAQUET CARDIOVASCULAR, LLC. | VH-3000 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |