BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO AIR FFM MED-AMER

    MDR report key: 5800597 · Received July 16, 2016

    Report

    Report Number
    3004604967-2016-00735
    Event Type
    Malfunction
    Date Received
    July 16, 2016
    Date of Event
    June 15, 2016
    Report Date
    July 15, 2016
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K123979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MASK HAS BEEN RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED THAT THE NON-VENTED QUATTRO AIR NV MASK HAD AN EXTERIOR PACKAGING LABELLED AS A VENTED QUATTRO AIR FULL FACE MASK SYSTEM. NO DEVICE WAS INVOLVED IN AN ADVERSE EVENT. THE DESIGN AUTHORITY, RESMED LTD, HAS THOROUGHLY INVESTIGATED THE MASK LABELING ISSUE AND THE ROOT CAUSE HAS BEEN ISOLATED TO MASK PACKAGING ON A SINGLE REWORK. THE PHYSICAL MASKS, VENTED QUATTRO AIR AND NON-VENTED QUATTRO AIR, ARE CLEARLY DISTINGUISHABLE IN FORM AND COLOR AS WELL AS A DIFFERENT ELBOW CONNECTION SIZE. IN RESPONSE TO OUR INVESTIGATION, RESMED IS ACTIVELY REVIEWING ADDITIONAL CONTAINMENT STEPS THAT MAY BE REQUIRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT 4 NON-VENTED QUATTRO AIR NV MASKS HAD AN EXTERIOR PACKAGING LABELLED AS A VENTED QUATTRO AIR FULL FACE MASK SYSTEM. IT WAS REPORTED THAT THE MASK WAS NOT PLACED ON A PATIENT; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454490 QUATTRO AIR FFM MED-AMER VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESMED LTD 62702 1142623

    Patients

    Seq Age Sex Outcome Treatment
    1