FDA Adverse Event
Other
Summary report: N
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT DPT
MDR report key: 1011978
·
Received March 10, 2008
Report
- Report Number
- 6000002-2008-06186
- Event Type
- Other
- Date Received
- March 10, 2008
- Date of Event
- February 22, 2008
- Report Date
- February 22, 2008
- Manufacturer
- EDWARDS LIFESCIENCES, DR
- 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
IT WAS REPORTED THAT THERE WAS AN UNK MATERIAL FOUND INSIDE OF THE TRANSDUCER, AND THE CUSTOMER DID NOT USE THE DEVICE. ME TRIED TO REMOVE THE UNK MATERIAL AND BROKE THE THREE WAY STOP COCK ABOVE THE SENSOR. 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 | 58419215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |