FDA Adverse Event
Other
Summary report: N
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT DPT
MDR report key: 1023751
·
Received March 24, 2008
Report
- Report Number
- 6000002-2008-06326
- Event Type
- Other
- Date Received
- March 24, 2008
- Date of Event
- March 10, 2008
- Report Date
- March 12, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, THERE WAS AN ADHESIVE LIKE UNKNOWN MATERIAL FOUND ON THE TRANSDUCER CABLE CONNECTOR AND IT WAS UNABLE TO BE USED. NOT PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT DPT | FLOTRAC SENSOR | DYG | EDWARDS LIFESCIENCES | MHD6S | 58453075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |