FDA Adverse Event
Malfunction
Summary report: N
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/ VAMP SYSTEM
MDR report key: 1013220
·
Received March 12, 2008
Report
- Report Number
- 6000002-2008-06146
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- January 7, 2008
- Report Date
- February 13, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION AT THIS TIME.
Description of Event or Problem · 1
THE CONNECTION BETWEEN VAMP AND TRANSDUCER CAME LOOSE AND THERE WAS A FLUID LEAK. THIS HAPPENED AFTER PATIENT HAD BEEN CONNECTED TO THE SET FOR TWO DAYS. CUSTOMER SAID IT SOUNDED LIKE "POFF" AND THEN IT CAME LOOSE. NO PATIENT WAS INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/ VAMP SYSTEM | CUSTOM DEFINED PRESSURE TRANSDUCER AND BLOOD SAMPLING KIT | DRS | EDWARDS LIFESCIENCES | T100500A | 58419825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |