BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTI J-HC CENTRIFUGE

    MDR report key: 4700929 · Received April 16, 2015

    Report

    Report Number
    3007448124-2015-00001
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Date of Event
    March 3, 2015
    Report Date
    March 19, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE REPORT THE CHECKBOX INDICATING INITIAL SHOULD HAVE BEEN CHECKED.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT. THE FSE FOUND THAT THE CHIP, WHICH SITS ON THE MOTOR DRIVER BOARD ASSEMBLY INSIDE THE CUSTOMER'S AVANTI J-HC CENTRIFUGE WAS BURNED. THE CUSTOMER WAS SENT A REPLACEMENT CHIP. THE CHIP WAS REPLACED, WHICH RESOLVED THE REPORTED ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE FIELD SERVICE ENGINEER REPORTED THE CHIP OF THE MOTOR DRIVER BOARD ASSEMBLY OF THE AVANTI J-HC CENTRIFUGE WAS BURNT. THE AVANTI J-HC CENTRIFUGE IS MANUFACTURED BY BECKMAN COULTER, BUT IS NOT REGISTERED AS A MEDICAL DEVICE IN THE UNITED STATES. THE MOTOR DRIVER BOARD ASSEMBLY (B)(4) IS USED IN ALL AVANTI SERIES INSTRUMENTS. THE AVANTI J6-MI AND AVANTI J26 XP/XPI ARE REGISTERED AS MEDICAL DEVICES. THERE WAS NO DEATH OR SERIOUS INJURY RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254412 AVANTI J-HC CENTRIFUGE CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE JQC BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1