FDA Adverse Event
Malfunction
Summary report: N
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
MDR report key: 1213992
·
Received October 20, 2008
Report
- Report Number
- 6000002-2008-09005
- Event Type
- Malfunction
- Date Received
- October 20, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 1, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DRS
- PMA / PMN Number
- K043065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TUBING WAS DETACHED. FOLLOW-UP WITH CUSTOMER INDICATED THAT THE DETACHED AREA WAS NEAR THE SENSOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR | FLOTRAC SENSOR | DRS | EDWARDS LIFESCIENCES | MDH6S | 58560629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |