BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR

    MDR report key: 14359593 · Received May 11, 2022

    Report

    Report Number
    3015238204-2022-00050
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Report Date
    May 11, 2022
    Manufacturer
    DEVILBISS HEADQUARTERS
    Product Code
    CAW
    PMA / PMN Number
    K071397
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH INOGEN, INC. IS NOT THE MANUFACTURER, AN INTERNAL INVESTIGATION WAS INITIATED TO DETERMINE THE CAUSE OF THE MALFUNCTION. INOGEN'S INVESTIGATION OF THE DEVICE IS COMPLETE. INOGEN WILL WRITE A SUPPLEMENTAL FILING WITH ANY ADDITIONAL INFORMATION GATHERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED FLUID ON HER LUNGS. IN TURN, THE PATIENT WAS HOSPITALIZED FOR FOUR DAYS IN (B)(6). AS A RESULT, THE PATIENT WAS INSTRUCTED BY THE MANUFACTURER TO REMOVE THE HUMIDIFIER FROM THE UNIT AND USE THE DEVICE WITHOUT THE HUMIDIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601396 DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES CAW DEVILBISS HEADQUARTERS 525 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Hospitalization