BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN ONE OXYGEN CONCENTRATOR

    MDR report key: 2534554 · Received March 16, 2012

    Report

    Report Number
    3004672275-2011-00001
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    December 15, 2010
    Report Date
    March 5, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INOGEN INC. HAS TESTED THE DEVICE AND SIX RECHARGEABLE BATTERY ASSEMBLIES ASSOCIATED WITH THIS EVENT. DEVICE WAS RECEIVED BY INOGEN IN DAMAGED CONDITION AS PER THE HEALTHCARE PROVIDERS RECEIPT FROM PATIENT. FIVE OF THE SIX RECHARGEABLE BATTERIES TESTED NOMINAL. ONE OF SIX BATTERIES FAILED RE-CHARGE TEST DUE TO EXPECTED LIFETIME LIMITATION. ALTHOUGH THIS EVENT WAS REPORTED TO FDA OR FEBRUARY 18, 2011 IN ORDER TO COMPLY WITH POTENTIAL 30 DAY REPORTING REQUIREMENT FOR REASONABLE SUGGESTION OF CONTRIBUTION TO SERIOUS INJURY AND WITH A CONSERVATIVE REPORTING JUDGEMENT BIAS, FURTHER REVIEW INDICATES A NON-REPORTABLE EVENT. DEVICE EVALUATION SUMMARY ATTACHED.

    Description of Event or Problem · 0

    PATIENT COMPLAINED OF SUSPECTED BATTERY POWER RELATED DEVICE MALFUNCTION RESULTING IN HOSPITALIZATION.

    Description of Event or Problem · 1

    PT COMPLAINED OF SUSPECTED DEVICE MALFUNCTION RESULTING IN HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37441 INOGEN ONE OXYGEN CONCENTRATOR PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization