FDA Adverse Event
Malfunction
Summary report: N
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER COMBO
MDR report key: 1112511
·
Received August 8, 2008
Report
- Report Number
- 6000002-2007-53710
- Event Type
- Malfunction
- Date Received
- August 8, 2008
- Date of Event
- June 30, 2008
- Report Date
- July 4, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DRS
- PMA / PMN Number
- K925638
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS NOT BEEN REC'D FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A DEVICE DEFECT. NO OTHER INFO WAS PROVIDED. SINCE THE POTENTIAL RISK OF THE DEFECT COULD NOT BE MEASURED, A MDR WAS REPORTED FOR THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER COMBO | DISPOSABLE PRESSURE MONITOR | DRS | EDWARDS LIFESCIENCES | T001691A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |