FDA Adverse Event
Summary report: N
MEDEX LOGICAL PRESSURE MONITORING SYSTEM
MDR report key: 2852612
·
Received November 14, 2012
Report
- Report Number
- 2852612
- Date Received
- November 14, 2012
- Date of Event
- October 17, 2012
- Report Date
- November 6, 2012
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- BYX
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
TRANSDUCER TUBING WOULDN'T 'CLICK' INTO TRANSDUCER HOLDER. HAD DIFFICULTY DETERMINING HEMODYNAMICS OF A POST OP AVR (AORTIC VALVE REPAIR) DUE TO THE LABILE NUMBERS AND TRANSDUCER NOT STAYING IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDEX LOGICAL PRESSURE MONITORING SYSTEM | TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR | BYX | SMITHS MEDICAL ASD, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |