BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 2171239 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00771
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COULTER ACT DIFF 2 ANALYZER IS LISTED BY CSA-INTERNATIONAL AS CONFORMING TO THE FOLLOWING STANDARDS FOR PRODUCT SAFETY: UL (B)(4), CSA (B)(4). (B)(4), AND IEC (B)(4). NOTE: CSA IS (B)(4) STANDARDS ASSOCIATION, UL IS UNDERWRITERS LABORATORIES, AND IEC IS INTERNATIONAL ELECTROTECHNICAL COMMISSION. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER. THE FSE IDENTIFIED A CAPACITOR ON THE POWER SUPPLY BOARD HAD CAUSED THE COMPONENT TO BURN UNTIL THE POWER SUPPLY SHUT DOWN. THE FSE REPLACED THE POWER SUPPLY, AND THE INSTRUMENT WAS FULLY FUNCTIONAL. THE ROOT CAUSE FOR SMOKE WAS A CAPACITOR ON THE POWER SUPPLY BOARD THAT CAUSED THE COMPONENT TO BURN UNTIL THE POWER SUPPLY SHUT DOWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL SAFETY HAZARD WHEN SMOKE WAS SEEN COMING FROM THE BACK OF THE COULTER ACT DIFF 2 ANALYZER. THE ANALYZER WAS DISCONNECTED FROM THE POWER SOURCE AND BECKMAN COULTER SERVICE WAS CONTACTED. THERE WERE NO FLAMES OR ARCING. THE FIRE DEPARTMENT WAS NOT CALLED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ACT DIFF 2 ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA