BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONAIRE

    MDR report key: 2844343 · Received November 8, 2012

    Report

    Report Number
    1319044-2012-00016
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 9, 2012
    Manufacturer
    AIRSEP CORP.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING RETURNED FROM (B)(6) TO AIRSEP CORPORATION IN THE USA FOR EVALUATION. A FOLLOW UP REPORT WILL BE SENT AFTER THE DEVICE HAS BEEN EVALUATED.

    Description of Event or Problem · 1

    SMOKE WAS COMING FROM DEVICE (OXYGEN CONCENTRATOR) AND IT WAS MOVED OUT OF HOUSE ONTO BALCONY WERE FIRE BROKE OUT. THE FIRE WAS PUT OUT WITH WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONAIRE OXYGEN CONCENTRATOR CAW AIRSEP CORP. AS098-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention