BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FP1000 CELL PREPARATION SYSTEM

    MDR report key: 2160276 · Received June 2, 2011

    Report

    Report Number
    1061932-2011-00537
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FSE EXAMINED THE INSTRUMENT AND DETERMINED DAMAGE WAS CONFINED TO THE RIGHT Q-PREP CONTROLLER BOARD AND WAS THE RESULT OF AN INTEGRATED CHIP (IC) ON THE CIRCUIT BOARD WHICH HAD RUPTURED AND PRODUCED THE SPARK, THE SOUND AND THE SMOKE. A REVIEW OF THE BOARD CONFIRMED THE OBSERVATION BY THE FSE. NO OTHER COMPONENTS WERE DAMAGED. ROOT CAUSE WAS THE FAILURE OF THE IC ON THE CIRCUIT BOARD. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, DURING THE INSTALLATION OF A FP1000 CELL PREPARATION SYSTEM, A BECKMAN COULTER INC EMPLOYEE, A FIELD SERVICE ENGINEER, REPORTED HEARING A POP, SEEING A SPARK, AND SMOKE COMING FROM THE INSTRUMENT. THE INSTRUMENT WAS TURNED OFF, THE POWER PLUG REMOVED FROM THE WALL, AND THE INSTRUMENT WAS EVALUATED BY THE FIELD SERVICE ENGINEER. THE INSTRUMENT DID NOT SUFFER ANY OTHER DAMAGE AND WAS RETURNED TO FULL OPERABILITY AFTER THE REPAIR. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT. THIS EVENT OCCURRED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FP1000 CELL PREPARATION SYSTEM JQW BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA