BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONAIRE

    MDR report key: 1829428 · Received August 25, 2010

    Report

    Report Number
    1319044-2010-00015
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 25, 2010
    Manufacturer
    AIRSEP CORPORATION
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WAITING FOR THE DEVICE TO RETURN FROM PRIMUS MEDICAL LLC, TO EVALUATE. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    MAINTENANCE MANAGER REPORTED AN OXYGEN CONCENTRATOR WAS SMOKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONAIRE OXYGEN CONCENTRATOR CAW AIRSEP CORPORATION AS098-4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA