FDA Adverse Event
Malfunction
Summary report: N
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER
MDR report key: 1040670
·
Received May 7, 2008
Report
- Report Number
- 6000002-2008-07059
- Event Type
- Malfunction
- Date Received
- May 7, 2008
- Date of Event
- March 20, 2008
- Report Date
- April 14, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, PT ARRIVED FROM THE OPERATING ROOM AND WHEN CARDIAC OUTPUT CABLE WAS CONNECTED TO VIGILANCE MONITOR, NO CARDIAC INDEX APPEARED UNTIL A MANUAL CARDIAC OUTPUT BOLUS WAS PERFORMED. AT 21:40 THE CARDIAC INDEX READ 1.0 AND A MANUAL BOLUS WAS DONE FOR A RESULT OF 2.1. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER | CONTINUOUS CARDIAC OUTPUT CATHETER | DYG | EDWARDS LIFESCIENCES | 746HF8 | 58430562 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |