BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 11792594 · Received May 7, 2021

    Report

    Report Number
    3015238204-2021-00002
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    March 23, 2021
    Report Date
    April 21, 2021
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    UDI-DI
    00817131020117
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITONAL INFORMATION: B5 CORRECTION INFORMATION: H6.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REVEALED THE ADVERSE EVENT WAS UNRELATED TO THE INOGEN DEVICE.

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS INITIATED TO DETERMINE THE CAUSE OF THE MALFUNCTION. THE INITIAL LOW O2 ERRORS WERE CAUSED BY A LEAKING PRODUCT MANIFOLD. TWELVE DAYS LATER THE COLUMNS WERE REMOVED AND RE-INSERTED. WHEN THE COLUMNS WERE PUT BACK IN, THEY WERE NOT FULLY SEATED INTO THE UNIT. THIS IS HOW THE COLUMNS BECAME CONTAMINATED WITH MOISTURE, REDUCING THE AMOUNT OF OXYGEN THAT COULD BE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S OXYGEN WAS DEPLETING. IN TURN THE PATIENTS ALARM DID NOT SOUND. AS A RESULT, THE PATIENT WAS ADMITTED TO THE HOSPITAL. REPORTEDLY, TROUBLESHOOTING WAS TRIED TO NO AVAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688898 INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-400 00817131020117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization