FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON LX 20 PRO CLINICAL SYSTEMS
MDR report key: 2020853
·
Received March 16, 2011
Report
- Report Number
- 2050012-2011-00742
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 21, 2011
- Report Date
- February 21, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K011213
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE TUBING.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THE HYDRO PNEUMATIC ON THE SYNCHRON LX 20 PRO CLINICAL SYSTEM LEAKED AT THE VALVE BANK DUE TO AGED TUBING. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON LX 20 PRO CLINICAL SYSTEMS | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | LX-20 PRO | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |