BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ROVE 4 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 25184547 · Received May 15, 2026

    Report

    Report Number
    3004672275-2026-00133
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 19, 2026
    Report Date
    May 15, 2026
    Manufacturer
    INOGEN INC.
    Product Code
    CAW
    UDI-DI
    00817131020414
    PMA / PMN Number
    K222086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT IS ESTIMATED. THE UNIT WAS RETURNED FOR EVALUATION ON 29-APR-2026. THE UNIT CAME IN FOR SERVICE NEEDED. THE COMPLAINT CONFIRMED. THE DATA SHOWS MULTIPLE 02 DELIVERY ERRORS THAT ARE CAUSED BY FEED WASTE, PROBABLY DROPPED UNITS. COLUMN SIEVE LIFE (0) THAT CAUSED BY ZEOLITE CONTAMINATED TOO MUCH ABSORBED MOISTURE. LOWER HOUSING BROKEN POSSIBLY DROPPED UNIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S UNIT HAD AN ERROR MESSAGE AND MADE A LOUD NOISE. AS A RESULT, THE UNIT WAS NOT PRODUCING ENOUGH OXYGEN AND CAUSED THE PATIENT TO PANIC. THE PATIENT HAD TO STAY AND DO BREATHING EXERCISES FOR SEVERAL HOURS TO CALM DOWN AS THEY DID NOT HAVE ANY BACKUP SOURCES WITH THEM. THERE WERE NO OTHER INTERVENTIONS AT THE TIME. THE PATIENT HAS RECEIVED THE REPLACEMENT UNIT AND IT IS WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513386 INOGEN ROVE 4 PORTABLE OXYGEN CONCENTRATOR INOGEN ROVE 4 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN INC. IO-401 00817131020414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other