BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICHEM VELOCITY

    MDR report key: 4223499 · Received October 29, 2014

    Report

    Report Number
    2023446-2014-00173
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2013
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K101852
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A LARGE NOISE AND THEN A BURNING SMELL FROM THE VELOCITY WAS REPORTED. AN IRIS FIELD SERVICE ENGINEER (FSE) OBSERVED THE BURNT SMELL FROM INSIDE THE ANALYZER CAUSED BY THE BURNT COMPONENTS FROM THE POWER SUPPLY. FSE REPLACED THE POWER SUPPLY AND THE ISSUE WAS RESOLVED. THERE WERE NO REPORTS OF INJURIES, VISIBLE FLAMES, SMOKE EMISSION, AND THE FIRE DEPARTMENT WAS NOT CALLED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BURNING SMELL FROM THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692770 ICHEM VELOCITY AUTOMATED URINE CHEMISTRY ANALYZER KQO IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other