BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 3897455 · Received May 22, 2014

    Report

    Report Number
    2023446-2014-00062
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE UNIT WAS NOT WORKING AND HARNESS FROM THE POWER SUPPLY WAS BURNED. NO ONE WAS INJURED. NO REPORTS OF FIRE, SMOKE, BURN SMELL,OR FIRE DEPARTMENT BEING CALLED, HOWEVER THERE IS EVIDENCE OF CHARRED MATERIAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PCB CABLE WAS BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306803 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1