BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 4071886 · Received August 12, 2014

    Report

    Report Number
    2023446-2014-00122
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BURNING SMELL WAS REPORTED FROM THE CENTRIFUGE UNIT. IT WAS FOUND THAT THE POWER SUPPLY INTERCONNECT CABLE WAS MELTED ONTO THE BOARD. NO INJURIES, OPEN FLAMES, OR SMOKE WAS REPORTED, NOR FIRE DEPARTMENT BEING CALLED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BURNING SMELL AND IMBALANCE ISSUE WITH THE EXPRESS 4 UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478974 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1