BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ONE OXYGEN CONCENTRATOR

    MDR report key: 1623738 · Received March 4, 2010

    Report

    Report Number
    3004672275-2010-00001
    Event Type
    Injury
    Date Received
    March 4, 2010
    Report Date
    February 28, 2010
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INOGEN HAS REVIEWED THE DETAILS OF THIS EVENT, INCLUDING FEEDBACK FROM MS BENEDICT. INOGEN DOES NOT BELIEVE THAT THE INOGEN CLINICIAN OR THE INOGEN ONE CONCENTRATOR ARE RESPONSIBLE FOR MS BENEDICT'S FALL. INOGEN HAS NEVER RECEIVED A REPORT OF ITS DEVICE CAUSING CO2 POISONING. OUR CLINICIANS DO NOT ADVISE PTS TO UTILIZE THEIR EQUIPMENT IN ANY WAY OTHER THAN TO THE PHYSICIAN'S PRESCRIPTION. THIS PT WAS TITRATED TO A SATURATION OF 96% AT REST ON SETTING 2, AND 95% DURING ADL'S ON SETTING 2.

    Description of Event or Problem · 1

    PT WAS ON A SETTING 2 UNDER NORMAL CONDITIONS. SHE INCREASED HER SETTING TO 4 AND PASSED OUT, FELL OVER, BROKE 3 RIBS, AND WAS HOSPITALIZED. HER DOCTOR TOLD HER, SHE SHOULD NEVER BE AT A SETTING 4 - SHE WILL GET CO2 POISONING. SHE STILL LOVES HER PRODUCT AND CONTINUES TO RECOMMEND IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOGEN ONE OXYGEN CONCENTRATOR PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization