BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROM PLUS COMPLETE KIT

    MDR report key: 6639599 · Received June 12, 2017

    Report

    Report Number
    MW5070395
    Event Type
    Malfunction
    Date Received
    June 12, 2017
    Date of Event
    June 12, 2017
    Report Date
    June 12, 2017
    Manufacturer
    CLINICAL INNOVATIONS
    Product Code
    NQM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRIOR TO USE, THE DEVICE WAS NOTED TO NOT HAVE THE FLUID INSIDE THE CASSETTE. FLUID WITHIN THE CASSETTE SHOULD BE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416667 ROM PLUS COMPLETE KIT ROM PLUS COMPLETE KIT NQM CLINICAL INNOVATIONS ROM-8025 161660

    Patients

    Seq Age Sex Outcome Treatment
    1 Other