BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC500

    MDR report key: 2312025 · Received October 27, 2011

    Report

    Report Number
    1061932-2011-01947
    Event Type
    Malfunction
    Date Received
    October 27, 2011
    Date of Event
    September 29, 2011
    Report Date
    September 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER UNIQUE IDENTIFICATION NUMBER IS (B)(4). THE POWERSOURCE PART NUMBER IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RUNNING THE CLEANING PANEL ON THE BECKMAN COULTER FC500 HEMATOLOGY INSTRUMENT, THE INSTRUMENT POWERED OFF COMPLETELY. THE CUSTOMER NOTICED A BURNING SMELL. THE CUSTOMER NOTICED THAT THE INSTRUMENT'S PLUG HAD MELTED ON ITS POWER CONDITIONER. THE CUSTOMER CALLED AN ELECTRICIAN TO LOOK INTO THE PROBLEM. THE ELECTRICIAN FOUND THAT THE POWER CONDITIONER HAD SHORTED OUT BECAUSE THE OUTLET THAT THE INSTRUMENT WAS PLUGGED INTO HAD MELTED. THE ELECTRICIAN REPAIRED THE HOSPITAL'S OUTLET. THERE WAS NO REPORT OF FLAMES, ARCING OR SHOCK. THE FIRE DEPARTMENT WAS NOT NOTIFIED OR A FIRE EXTINGUISHER WAS NOT REQUIRED. THE CUSTOMER WAS ABLE TO BYPASS THE DEFECTIVE POWER CONDITIONER AND WAS ABLE TO RUN SAMPLES. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS COMPLAINT. THE FIELD SERVICE ENGINEER (FSE) OBSERVED THAT THE POWER CONDITIONER HAD SHORTED OUT. A NEW POWER CONDITIONER WAS SENT TO THE CUSTOMER. THE DEFECTIVE PART WILL BE SENT BACK TO BECKMAN COULTER, INC. (BCI) FOR EVALUATION. THE ROOT CAUSE FOR THIS INCIDENT WAS ATTRIBUTED TO THE POWER CONDITIONER SHORTING OUT. THE POWER CONDITIONER IS LISTED BY ITS MANUFACTURER, POWERVAR, TO UL 1012 WITH VENDOR MODEL NUMBER: POWERVAR ABC 1600-11. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FC500 COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. FC 500

    Patients

    Seq Age Sex Outcome Treatment
    1