BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ONE G2 OXYGEN CONCENTRATOR

    MDR report key: 1897444 · Received November 3, 2010

    Report

    Report Number
    3004672275-2010-00003
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    August 28, 2010
    Report Date
    October 18, 2010
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    PMA / PMN Number
    K032818
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INOGEN, INC HAS TESTED THE DEVICE ASSOCIATED WITH THIS EVENT. INOGEN DID NOT FIND ANY TROUBLE WITH UNIT; AWAITING MEDICAL RECORDS FOR FURTHER VERIFICATION.

    Description of Event or Problem · 1

    PATIENT WENT TO ER; STATED OUTPUT FROM POC OF POOR QUALITY AND DAMAGING TO LUNGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOGEN ONE G2 OXYGEN CONCENTRATOR PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other