FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION LXT
MDR report key: 2048250
·
Received April 5, 2011
Report
- Report Number
- MW5020178
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 5, 2011
- Manufacturer
- ALCON LABORATORIES
- Product Code
- HQC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CONSTELLATION LXT S/N (B)(4) STOPPED VACUUMING DURING CASE. NEW HAND PIECE CONNECTED, EQUIPMENT DID NOT WORK. ALL TUBING AND CARTRIDGE CHANGED AND STILL DID NOT WORK. MACHINE TAKEN OUT OF SERVICE AND TAGGED. SUPERVISOR NOTIFIED. NEW MACHINE CONNECTED AND WORKED PROPERLY. NO INJURY NOTED TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSTELLATION LXT | CONSTELLATION LXT | HQC | ALCON LABORATORIES | CONSTELLATION LXT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |