BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX CLINICAL SYSTEM

    MDR report key: 1873165 · Received October 18, 2010

    Report

    Report Number
    2050012-2010-01004
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) FOUND THE CONNECTION ON THE 220V AC LINE FROM INSTRUMENT TO THE UPS FAILED. THE FSE REPLACED THE POWER CABLE WITH THE CUSTOMER STOCK. PER LABELING, BECKMAN COULTER SYSTEMS HAVE THE CE MARK OR UL/CSA APPROVALS WHICH MEANS THE SYSTEMS MEET THE ELECTRICAL SAFETY STANDARDS, AND ARE MADE OF MATERIALS THAT WILL NOT SUPPORT OR SUSTAIN COMBUSTION, AND ARE SELF EXTINGUISHING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A SPARK AND SMOKE OBSERVED FROM SYNCHRON CX9 ALX CLINICAL SYSTEM. BCI HOTLINE ADVISED THE CUSTOMER TO TURN OFF THE INSTRUMENT AND UNPLUG ALL POWER CABLES FROM THE SOCKET. BCI HOTLINE GENERATED SERVICE IMMEDIATELY. NO ONE WAS INJURED OR EXPOSED TO SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX9 ALX CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1