BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSPIN MP

    MDR report key: 4030377 · Received July 29, 2014

    Report

    Report Number
    2023446-2014-00096
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    IRIS DIAGNOSTICS
    Product Code
    GKG
    PMA / PMN Number
    K920759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED A BURNING SMELL AND VISIBLE SMOKE WHILE CENTRIFUGE WAS IN USE. UPON OPENING THE UNIT, IT WAS OBSERVED THAT THE O-RING HAD POPPED OUT OF THE ROTOR AND HAD MELTED INSIDE THE UNIT. THERE WAS NO HARM DUE TO THIS INCIDENT AND NO ONE REQUIRED MEDICAL ATTENTION. THERE WERE NO REPORTS OF VISIBLE FLAMES NOR FIRE DEPARTMENT BEING CALLED.

    Description of Event or Problem · 1

    CUSTOMER NOTED SMOKE COMING OUT OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442553 STATSPIN MP GKG IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1