BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FALL MEDICAL Q POINT STERILIZING GRADE WATER FILTER

    MDR report key: 8037885 · Received November 2, 2018

    Report

    Report Number
    MW5081037
    Event Type
    Injury
    Date Received
    November 2, 2018
    Date of Event
    May 12, 2018
    Report Date
    October 25, 2018
    Manufacturer
    PALL CORPORATION
    Product Code
    NHV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    POINT OF USE WATER FILTER USED IN PT ROOM TO CONTROL LEGIONELLA PNEUMOPHILA APPEARED TO HAVE FAILED. MFR BELIEVES DUE TO HIGH WATER PRESSURE EVENT. MFR INSPECTION (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872272 FALL MEDICAL Q POINT STERILIZING GRADE WATER FILTER SYSTEM WATER PURIFICATION, GENERAL MEDICAL USE NHV PALL CORPORATION QJ212A 18-3022

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization