BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTI J-25

    MDR report key: 2055045 · Received April 13, 2011

    Report

    Report Number
    2050012-2011-01103
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQC
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. A POWER DRIVER ON THE SR INVERTER EXPERIENCED ELECTRICAL OVERSTRESS CAUSING THE COMPONENT ON THE BOARD TO OVERHEAT AND RUPTURE. THE INSTRUMENT INVERTER BOARD CONTAINED THE DAMAGE AND PREVENTED DAMAGE FROM SPREADING TO OTHER PARTS OF INSTRUMENT. FSE NOTED NO OTHER DAMAGE TO THE INSTRUMENT AT THE TIME OF INSPECTION, AND INSTRUMENT HAD THE APPROPRIATE SAFETY RATINGS. FSE REPLACED POWER DRIVER AND SR INVERTER BOARD, AND INSTRUMENT WAS VERIFIED TO BE OPERATIONAL. ROOT CAUSE WAS ASSOCIATED WITH SLIGHT BURNING PLASTIC SMELL, DUE TO ELECTRICAL OVERSTRESS CAUSING A BOARD COMPONENT TO OVERHEAT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A BURNING SMELL IN CONNECTION WITH THE AVANTI J-25 CENTRIFUGE. THERE WAS NO SMOKE OR FIRE, AND THE FIRE DEPARTMENT WAS NOT CONTACTED. THERE WERE NO REPORTS OF INJURY OR PROPERTY DAMAGE TO THE FACILITY CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTI J-25 CENTRIFUGATION INSTRUMENT JQC BECKMAN COULTER INC. AVANTI J-25 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1