BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 3897453 · Received May 22, 2014

    Report

    Report Number
    2023446-2014-00063
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED A BURNING/HOT SMELL FROM THE UNIT AND BURN PIN ON THE CONTROL BOARD. THERE WERE NO FLAMES OR SMOKE, HOWEVER THERE'S EVIDENCE OF CHARRED MATERIAL. THE FIRE DEPARTMENT WAS NOT CALLED. NO PATIENT SAMPLES WERE LOST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BURNING SMELL FROM THE CENTRIFUGE UNIT AND SAW BURNT BOARD PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306985 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1