BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT 5DIFF CAP PIERCE (CP)

    MDR report key: 2171211 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00773
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COULTER ACT 5DIFF CAP PIERCE (CP) HAS THE FOLLOWING PRODUCT SAFETY COMPLIANCE APPROVALS: UL (B)(4), CSA (B)(4), AND EN (B)(4). NOTE: CSA IS (B)(4) STANDARDS ASSOCIATION, UL IS UNDERWRITERS LABORATORIES, AND EN IS EN STANDARDS FOR PRODUCTS AND SERVICES BY EUROPEAN COMMITTEE FOR STANDARDIZATION. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND FOUND DEBRIS IN THE COOLING FAN AT THE BATH LOCATION. THE DEBRIS WAS PREVENTING THE FAN BLADE FROM TURNING. THIS CAUSED A COMPONENT TO OVER HEAT. THE FSE REMOVED THE DEBRIS AND VERIFIED INSTRUMENT PERFORMANCE TO SPECIFICATIONS. ROOT CAUSE FOR THE SMOKE/BURNING SMELL WAS DEBRIS IN A COOLING FAN CAUSED A COMPONENT TO OVER HEAT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SMOKE AND BURNING SMELL FROM THE COULTER ACT 5DIFF CAP PIERCE (CP) WHILE PERFORMING AN EXTENDED CLEAN CYCLE. THE UNIT WAS DISCONNECTED FROM POWER AND SERVICE WAS REQUESTED. THERE WERE NO FLAMES REPORTED. THE FIRE DEPARTMENT WAS NOT CALLED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO EFFECT ON OPERATOR SAFETY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ACT 5DIFF CAP PIERCE (CP) GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA