FDA Adverse Event
Malfunction
Summary report: N
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/VAMP KIT
MDR report key: 1013218
·
Received March 12, 2008
Report
- Report Number
- 6000002-2008-06155
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- February 27, 2008
- Report Date
- February 27, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS NOT BEEN RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TUBING CONNECTED TO THE VAMP CAME APART ON THE ARTERIAL SIDE AND FLUID CAME OUT AND SPRAYED THE PT. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/VAMP KIT | DISPOSABLE PRESSURE MONITOR AND BLOOD SAMPLING KIT | DRS | EDWARDS LIFESCIENCES | PXVMP120 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |