BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIONAIRE V

    MDR report key: 3130041 · Received May 22, 2013

    Report

    Report Number
    1319044-2013-00006
    Event Type
    Other
    Date Received
    May 22, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 22, 2013
    Manufacturer
    AIRSEP CORP.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FIRE WAS CAUSED BY EXTERNAL IGNITION OF THE CANNULA TUBING. PHOTOGRAPHS FROM THE FIRE SCENE SHOW THE CANNULA TUBING BURNT TO THE BED POST AND INTO THE CARPET. THE OXYGEN CONCENTRATOR CABINET WAS DAMAGED BY THE CANNULA BURNING BACK TO THE OXYGEN OUTLET WERE THE FIRE STOPPED. THE OXYGEN CONCENTRATOR IS OPERATIONAL.

    Description of Event or Problem · 1

    OXYGEN CONCENTRATOR INVOLVED IN A TRAILER FIRE. DAMAGE TO CARPET AND BED POST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227540 VISIONAIRE V OXYGEN CONCENTRATOR CAW AIRSEP CORP. AS098-101

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention