BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPHROS

    MDR report key: 8652580 · Received May 29, 2019

    Report

    Report Number
    3003337893-2019-00001
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 29, 2019
    Manufacturer
    NEPHROS
    Product Code
    NHV
    PMA / PMN Number
    K153084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS UNDERWAY. WE ARE AWAITING FINAL INVESTIGATION RESULTS AND LABORATORY RESULTS. UPON COMPLETION, THE INFORMATION WILL BE REVIEWED AND THE FINDING PUBLISHED. ANTICIPATED COMPLETION DATE: JUNE 07TH 2019.

    Description of Event or Problem · 1

    THE INVESTIGATION IS CURRENTLY UNDERWAY. THE MANUFACTURE WAS INFORMED THAT THE CUSTOMER EXPERIENCED A POSITIVE LEGIONELLA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445150 NEPHROS S100 NHV NEPHROS S100 PI17/0180

    Patients

    Seq Age Sex Outcome Treatment
    1