BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 5553849 · Received October 29, 2014

    Report

    Report Number
    2023446-2014-00175
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    IRIS DIAGNOSTICS
    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

    POWER HARNESS AND BOARD MELTED AT THE PLUG WAS REPORTED ON THE STATSPIN EXPRESS 4 CENTRIFUGE. THERE WERE NO REPORTS OF INJURIES, OPEN FLAMES, SMOKE EMISSION OR THE FIRE DEPARTMENT BEING CALLED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE MAIN BOARD BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694797 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1