BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2183440 · Received July 28, 2011

    Report

    Report Number
    2050012-2011-03321
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND REPLACED THE POWER STRIP AND MOUNTED ALL POWER STRIPS TO WALL AND OFF OF FLOOR. FSE INSTALLED A COVER OVER THE FLOOR DRAIN AND DRILLED HOLES FOR TUBING TO ELIMINATE SPLASHING FROM THE DRAIN. FSE MOVED CONSOLES AND OTHER PERIPHERALS AS FAR FROM DI (DEIONISED) WATER CANISTER AS SETUP WOULD ALLOW. INSTRUMENT WAS POWERED UP AND OPERATION WAS VERIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THEIR SURGE PROTECTOR BECAME WET AND STARTED TO SMOKE. THE CUSTOMER SHUTDOWN THE INSTRUMENT AND UNPLUGGED THE POWER STRIP AND UPS. THE CUSTOMER DID NOT KNOW WHETHER THE WATER CAME FROM THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM OR AN EXTERNAL SOURCE. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1