BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOWER ASSEMBLY

    MDR report key: 2035201 · Received March 31, 2011

    Report

    Report Number
    2050012-2011-00920
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQC
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INVENTORY WAS PULLED AND INSPECTED. NO OTHER ASSEMBLIES WERE FOUND TO BE MISWIRED. THE MANUFACTURING INSTRUCTIONS WERE ALSO CHECKED AND WERE FOUND TO BE CORRECT. NO POTENTIAL ROOT CAUSE HAS YET BEEN IDENTIFIED FOR THE MISWIRED ASSEMBLY. NOTE: THIS EVENT WAS REPORTED ON BEHALF OF THE PRODUCT CODE - JQC FOR THE J2-21 M HIGH CAPACITY CENTRIFUGE, WHICH IS ASSOCIATED WITH THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE BLOWER ASSEMBLY ON THE J2-21 M HIGH CAPACITY CENTRIFUGE WAS ORDERED AS A SPARE PART AND WAS FOUND TO BE MISWIRED BY THE FIELD SERVICE ENGINEER (FSE). THE MISWIRING ENERGIZED THE ENTIRE FRAME OF THE INSTRUMENT, CREATING THE POTENTIAL FOR SHOCK TO THE USER. NO INJURY WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOWER ASSEMBLY CENTRIFUGATION COMPONENT JQC BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1