BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2377013 · Received December 15, 2011

    Report

    Report Number
    1061932-2011-02633
    Event Type
    Malfunction
    Date Received
    December 15, 2011
    Date of Event
    November 17, 2011
    Report Date
    November 17, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE A BURNT SMELL FROM THE COULTER HMX ANALYZER WITH AUTOLOADER (HMX AUTOLOADER). CUSTOMER REPORTED THAT THE PELTIER FAN WAS NOT WORKING. CUSTOMER REPORTED THAT THEY REPLACED THE PELTIER ASSEMBLY AND RAN QUALITY CONTROL (QC). THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER HMX ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. HMX AUTOLOADER

    Patients

    Seq Age Sex Outcome Treatment
    1