FDA Adverse Event
Malfunction
Summary report: N
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT DPT
MDR report key: 1014097
·
Received March 14, 2008
Report
- Report Number
- 6000002-2008-06228
- Event Type
- Malfunction
- Date Received
- March 14, 2008
- Date of Event
- February 27, 2008
- Report Date
- February 28, 2008
- Manufacturer
- EDWARDS LIFESCIENCES, DR
- Product Code
- DYG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, THE ARTERIAL LINE WAS NOT CONNECTED TO THE LUER LOCK AT THE SIDE OF THE SENSOR BEFORE USE. IT WAS FURTHER REPORTED THAT IT APPEARED AS IF THE LINE WAS CUT. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT DPT | FLO TRAC SENSOR | DYG | EDWARDS LIFESCIENCES, DR | MHD8 | 58428835 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |