BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX CLINICAL SYSTEM

    MDR report key: 2232164 · Received September 2, 2011

    Report

    Report Number
    2050012-2011-04759
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. A) THE CUSTOMER EXPLAINED TO THE FSE THAT THE BURNING ODOR WAS EMANATING FROM THE CARD CAGE AREA. B) THE FSE BRUSHED OFF DUST FROM THE CARDS IN THE CARD CAGE; NO BURNT COMPONENTS WERE FOUND. C) THE POWER CORD WAS PLUGGED IN BY FSE INTO THE UNINTERRUPTIBLE POWER SUPPLY (UPS) AND UPS FAULT CODES OCCURRED. D) THE CUSTOMER WAS ADVISED BY THE FSE THAT THE BURNING ODOR LIKELY CAME FROM THE UPS LOCATED ON THE RIGHT SIDE OF THE INSTRUMENT AND ODOR WAS SUCKED IN BY THE REAGENT SIDE INSTRUMENT FAN WHICH FLOWS UP THROUGH THE CARD CAGE. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THERE WAS A BURNING ODOR COMING FROM THE SYNCHRON CX9 ALX CLINICAL SYSTEM. THE CUSTOMER WAS ADVISED BY CUSTOMER TECHNICAL SUPPORT (CTS) TO DISCONNECT THE POWER TO THE INSTRUMENT. THE CUSTOMER DID NOT OBSERVE SMOKE COMING FROM THE INSTRUMENT. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX9 ALX CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX9 ALX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1