BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC500 FLOW CYTOMETER WITH CXP SOFTWARE

    MDR report key: 3607109 · Received February 4, 2014

    Report

    Report Number
    1061932-2014-00238
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 6, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K030828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND DISCOVERED A DAMAGED CABLE INSIDE THE POWER SUPPLY HARNESS WITHIN THE POWER SUPPLY ASSEMBLY. THE DAMAGED CABLE RESULTED IN ONE OF THE CONNECTORS (J106/P106) TO MELT CREATING THE BURNING SMELL. THE FSE PERFORMED A THOROUGH CHECK AND NO OTHER ELECTRICAL SHORTING WAS REVEALED. THE FSE REPLACED THE POWER SUPPLY HARNESS TO RESOLVE THE ISSUE AND VERIFIED THE REPAIRS PER ESTABLISHED PROCEDURES. RESULTS: FAILURE MODE OF THE EVENT IS ATTRIBUTED TO A MALFUNCTIONING POWER SUPPLY HARNESS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BURNING SMELL FROM NEAR THE FC500 FLOW CYTOMETER WITH (B)(4) SOFTWARE AND PROCEEDED TO SHUT DOWN THE INSTRUMENT. THERE WAS NO FIRE, SPARKS, OR SMOKE ASSOCIATED WITH THE EVENT AND NO INJURY WAS REPORTED. THERE WAS NO IMPACT TO PATIENT RESULTS SINCE THE INSTRUMENT WAS UNABLE TO BE TURNED ON AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72044 FC500 FLOW CYTOMETER WITH CXP SOFTWARE COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1