BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1946022 · Received January 4, 2011

    Report

    Report Number
    2050012-2010-01749
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE POWERED INSTRUMENT DOWN, VERIFIED POWER PLUG AND POWER SUPPLIES, REMOVED TOP AND REAR PANELS, CHECKED EVENT LOG, PERFORMED A SMELL TEST AROUND THE INSTRUMENT. NO ISSUE WAS DETECTED. SYSTEM IS OPERATING ACCEPTABLY NOW. BECKMAN COULTER SYSTEMS HAVE THE (B)(4) APPROVALS WHICH MEANS THE SYSTEMS MEET THE ELECTRICAL SAFETY STANDARDS, 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) AND STATED THEY NOTED A SPARKING NOISE AND A BURNING SMELL ON UNICEL DXC 800 SYNCHRON CLINICAL SYSTEMS. CUSTOMER DID NOT SEE SMOKE OR FIRE. CUSTOMER SHUT DOWN THE INSTRUMENT AND UNPLUGGED THE POWER CORD. NO OPERATOR EXPOSURE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1