FDA Adverse Event
Malfunction
Summary report: N
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER
MDR report key: 1213994
·
Received October 20, 2008
Report
- Report Number
- 6000002-2008-09004
- Event Type
- Malfunction
- Date Received
- October 20, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 1, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYG
- PMA / PMN Number
- K040287
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CONTINUOUS CARDIAC OUTPUT NUMBERS WERE NOT ACCURATE IT TOOK 15-20 MINUTES TO DISPLAY AND THE NUMBERS WERE INCORRECT, ERROR MESSAGE OBSERVED "BLOOD TEMP." SALES REP., STATED THAT THIS WAS A "CLOSE CALL", MANUAL BOLUS PERFORMED, VERIFIED THE NUMBERS WERE INCORRECT. PATIENT WAS STABILIZED AND NO ADVERSE EFFECTS.
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 | 777HF8 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |