FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
MDR report key: 2221135
·
Received August 23, 2011
Report
- Report Number
- 2050012-2011-04718
- Event Type
- Malfunction
- Date Received
- August 23, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 10, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS A VENDOR SUPPLIED PRODUCT, THEREFORE, THE CUSTOMER WAS REFERRED TO THE VENDER (INTELLIGENT POWER) TO PERFORM TROUBLESHOOTING AND TO RESOLVE THE ISSUE. A BEC FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT. (B)(4).
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THE UNINTERRUPTIBLE POWER SUPPLY (UPS) WAS NOT FUNCTIONING PROPERLY AND A BURNING ODOR WAS COMING FROM THE UPS UNIT IN THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. NO INJURY WAS REPORTED FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 600 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |