FDA Adverse Event
Malfunction
Summary report: N
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
MDR report key: 1030820
·
Received April 17, 2008
Report
- Report Number
- 6000002-2008-05685
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Date of Event
- February 20, 2007
- Report Date
- November 29, 2007
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE REPORTED COMPLAINT IS UNK. NO FURTHER DETAILS WERE FORTHCOMING. REPORTEDLY, THERE WERE NO PT COMPLICATION OR INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER | DISPOSABLE PRESSURE TRANSDUCER | DRS | EDWARDS LIFESCIENCES | PX2X2 | 58256893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |