BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 3902121 · Received May 6, 2014

    Report

    Report Number
    2023446-2014-00051
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED BURNING ODOR FROM THE CENTRIFUGE WHILE IT WAS RUNNING AND OBSERVED THAT THE POWER INTERCONNECT CABLE GOING TO THE PCB BOARD IS MELTED. THE UNIT POWERED ON BUT NO LIGHTS WAS SHOWING. THERE WERE NO REPORTS OF SMOKE OR FIRES. NO ONE WAS EXPOSED OR HAD TO BE TREATED AND NO INJURIES WERE REPORTED. NO ERRONEOUS RESULTS WAS GENERATED. FIRE DEPARTMENT WAS NOT CALLED, HOWEVER, THERE IS EVIDENCE OF CHARRED MATERIAL .

    Description of Event or Problem · 1

    CUSTOMER REPORTED BURNING SMELL FROM THE UNIT AND THE PCB LOOKED BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271960 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1