BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONAIRE

    MDR report key: 1930154 · Received November 22, 2010

    Report

    Report Number
    1319044-2010-00023
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 22, 2010
    Manufacturer
    AIRSEP CORP.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRESENTLY WAITING FOR DEVICE TO RETURN FROM SPAIN FOR EVAL. A F/U REPORT WILL BE SUBMITTED AFTER EVAL IS COMPLETED.

    Description of Event or Problem · 1

    BURNT VISIONAIRE OXYGEN CONCENTRATOR.

    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