BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTI J-HC HIGH-CAPACITY CENTRIFUGE

    MDR report key: 3511777 · Received December 10, 2013

    Report

    Report Number
    3007448124-2013-00004
    Event Type
    Malfunction
    Date Received
    December 10, 2013
    Date of Event
    November 11, 2013
    Report Date
    November 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH SYSTEM TROUBLESHOOTING. IN CONCLUSION, A FAULTY INVERTER BOARD IS THE LIKELY CAUSE OF THE EVENT. BECKMAN COULTER CONTINUES TO TRACK AND TREND ANY INCIDENT RELATED TO THIS ISSUE. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER (FIELD SERVICE ENGINEER) REPORTED THE AVANTI J-HC HIGH-CAPACITY CENTRIFUGE'S 20-AMP FUSE BURNED OUT DURING SYSTEM STARTUP AND DAMAGED THE R7 RESISTOR. THE FSE NOTED TRANSISTORS Q1 AND Q2 WERE SHORTED. THE CENTRIFUGE GENERATED A P2 ERROR (POWER DIAGNOSTIC ERROR DROPPED TO SMALLER THAN 5% OF SET SPEED) INTERRUPTING POWER TO THE INSTRUMENT. AFTER REAPPLYING POWER TO THE INSTRUMENT, IT SHORTED AGAIN, IN THE R7 RESISTOR AREA. AFTER REMOVING THE INVERTER BOARD (MOTOR DRIVER BOARD), ALL VOLTAGES ON THE TRANSFORMERS WERE VERIFIED AND WERE WITHIN TOLERANCE. THE FSE DETERMINED THERE WAS A SHORT-CIRCUIT IN THE INVERTER BOARD AND REPLACED THE INVERTER BOARD. THERE WAS NO OPERATOR INJURY OR IMPACT TO PATIENT RESULTS ASSOCIATED WITH THIS EVENT. NO FIRE OR SMOKE WAS OBSERVED. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646231 AVANTI J-HC HIGH-CAPACITY CENTRIFUGE CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE JQC BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1