FDA Adverse Event
Malfunction
Summary report: N
CDP UNKNOWN
MDR report key: 2011026
·
Received March 8, 2011
Report
- Report Number
- 2015691-2011-14976
- Event Type
- Malfunction
- Date Received
- March 8, 2011
- Date of Event
- February 8, 2011
- Report Date
- February 8, 2011
- Manufacturer
- EDWARDS LIFESCIENCES DR
- Product Code
- DXO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE WAS RETURNED BECAUSE THE DEVICE WAS DISCARDED; THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED BY EVALUATION. THE DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT "PRESSURE MEASUREMENT WAS INACCURATE DURING USE. IT INDICATED MINUS VALUE." DEVICE WAS DISCARDED AT THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CDP UNKNOWN | PRESSURE MONITORING KIT | DXO | EDWARDS LIFESCIENCES DR | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |