BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ200

    MDR report key: 4254616 · Received November 13, 2014

    Report

    Report Number
    2023446-2014-00177
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 24, 2014
    Manufacturer
    IRIS DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K022774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BURNING SMELL WAS REPORTED FROM THE IQ 200. IRIS FIELD SERVICE ENGINEER (FSE) INSPECTED INSTRUMENT AND FOUND BACKPLANE AT STM SSMB BOARD/POWER SIC CHIP WAS BURNED. THE INSTRUMENT WILL BE REPLACED DUE TO RESULTING DAMAGE FROM FAILED PCB BOARDS. FIRE DEPARTMENT WAS NOT CALLED AND NO REPORTS OF INJURIES OR MEDICAL INTERVENTIONS WERE MADE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BURNING SMELL FROM THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732859 IQ200 AUTOMATED URINE MICROSCOPY ANALYZER KQO IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1