BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ 200 SYSTEM

    MDR report key: 6122992 · Received November 22, 2016

    Report

    Report Number
    2023446-2016-00406
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 2, 2016
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K022774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER SITE AND OBSERVED THAT THE F17 FUSE AND HOUSING MELTED, WITH BLACK MARKS ON FRONT AND BACK OF PCB AND POWER SIC CABLE. THE CAUSE OF THE FUSE DAMAGE WAS AN OVER CURRENT (POWER SURGE). THE CAUSE OF THE POWER SURGE IS UNKNOWN. THE FSE REPLACED THE MELTED/CHARRED COMPONENT. THE REPAIRS WERE VERIFIED AS PER SERVICE PROCEDURES. THE FOLLOWING SAFETY RATINGS APPLY TO THE IQ200 ELITE: ·ANSI/UL 61010-1, SECOND EDITION, DATED JULY 12, 2004 - "SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE; PART 1: GENERAL REQUIREMENTS." ·CAN/CSA-C22.2 NO. 61010-1, SECOND EDITION, JULY 12, 2004 - "SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE; PART 1: GENERAL REQUIREMENTS." ·IEC/EN 61010-2- 081, PART 2-081: "SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE" PARTICULAR REQUIREMENTS FOR AUTOMATIC AND SEMI-AUTOMATIC LABORATORY EQUIPMENT FOR ANALYSIS AND OTHER PURPOSES). ·(IEC/EN 61010-2- 101, PART 2: "SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE" PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSTRUMENT HAD A LOUD NOISE AND BURNING SMELL ON THEIR IQ200 ELITE. THERE WERE NO ERRONEOUS RESULTS GENERATED OR REPORTED OUT OF THE LAB. THERE WAS NO IMPACT TO PATIENT OR CHANGE IN PATIENT TREATMENT. THE CUSTOMER REPORTED ONLY A LOUD NOISE AND BURNING SMELL. THERE WAS NO FIRE OR SMOKE REPORTED AS A RESULT OF THIS EVENT. THE FIRE DEPARTMENT WAS NOT CALLED AND LAB WAS NOT EVACUATED. NO ONE SOUGHT MEDICAL ATTENTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773841 IQ 200 SYSTEM AUTOMATED URINALYSIS SYSTEM KQO IRIS INTERNATIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1