BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 3957281 · Received June 17, 2014

    Report

    Report Number
    2023446-2014-00068
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE EXPRESS 4 CENTRIFUGE WAS INOPERABLE. UPON FURTHER INVESTIGATION, THERE WAS EVIDENCE OF CHARRED MATERIALS AT THE POWER HARNESS PLUG. NO REPORTS OF INJURIES, SMOKE, BURN SMELL, VISIBLE FLAMES, OR FIRE DEPARTMENT BEING CALLED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE EXPRESS 4 CENTRIFUGE WAS DEAD AND THE POWER HARNESS PLUG BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355081 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1