BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONAIRE

    MDR report key: 1900104 · Received October 22, 2010

    Report

    Report Number
    1319044-2010-00020
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 22, 2010
    Manufacturer
    AIRSEP CORP.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISIONAIRE OXYGEN CONCENTRATOR IS BEING RETURNED TO AIRSEP CORPORATION FOR EVAL. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    VISIONAIRE OXYGEN CONCENTRATOR CAUGHT FIRE. FIRE EXTINGUISHED WITHOUT INJURY OR PROPERTY DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONAIRE OXYGEN CONCENTRATOR CAW AIRSEP CORP. AS098-1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention