FDA Adverse Event
Malfunction
Summary report: N
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR/SENSOR
MDR report key: 1213996
·
Received October 20, 2008
Report
- Report Number
- 6000002-2008-09002
- Event Type
- Malfunction
- Date Received
- October 20, 2008
- Date of Event
- March 21, 2007
- Report Date
- March 21, 2007
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DRS
- PMA / PMN Number
- K043065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RECEIVED (1) COMPLETE FLOTRAC KIT. TUBING WAS SNAPPED/BROKEN AT THE BOND JOINT WITH THE FEMALE CONNECTOR (ATTACHED TO ZERO-STOPCOCK). BROKEN TUBING WAS BENT NEAR THE BOND JOINT. BONDING SOLVENT COMPLETELY FILLED UP ALL THE GAP AROUND THE FLARED PORTION OF THE CONNECTOR TUBE HOUSING. BONDING SOLVENT WAS ALSO EVIDENT ON THE BROKEN END OF THE TUBING. HOWEVER, BOTH FLOTRAC SENSOR AND DPT ZEROED AND SENSED PRESSURE ACCURATELY.
Description of Event or Problem · 1
INITIALLY REPORTED AS AN UNKNOWN COMPLAINT. ORIGINAL RGA WAS NOT REFERENCED BY CUSTOMER AT TIME OF RETURN. MODEL NUMBER WAS UNKNOWN; HOWEVER, THE DEVICE WAS IDENTIFIED AS A FLOTRAC SENSOR. NEW INFORMATION WAS PROVIDED WHEN DEVICE WAS EVALUATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR/SENSOR | FLOTRAC SENSOR | DRS | EDWARDS LIFESCIENCES | CCUNKNOWN | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |