BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 17838040 · Received September 28, 2023

    Report

    Report Number
    3015238204-2023-00008
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 4, 2023
    Report Date
    September 28, 2023
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    PMA / PMN Number
    K032818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B5 RESPONSE TO MEDWATCH 5122856, MW5122857, MW5122858, MW5122859, MW5122860 AN INTERNAL INVESTIGATION WAS INITIATED TO DETERMINE THE CAUSE OF THE MALFUNCTION. SAFETY AND EFFICACY OF THE DEVICE IS PARAMOUNT FOR THE PRODUCTS WE MANUFACTURE AND PROVIDE TO OUR CUSTOMERS. RETURNED PARTS ARE REPAIRED - UNDER WARRANTY. IT IS IMPORTANT TO NOTE THAT WE HAVE AN EFFECTIVE POST MARKET SURVEILLANCE PROGRAM TO ADDRESS SUCH CONCERNS AND OUR RISK MANAGEMENT PROGRAM IS COMPLIANT TO ISO 14971:2019. WE WILL TREAT THESE COMPLAINTS (REF (B)(4)) IN THE SAME MANNER.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2095663 INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown