BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO AIR FFM MED-AMER

    MDR report key: 5824661 · Received July 26, 2016

    Report

    Report Number
    3004604967-2016-00806
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    June 27, 2016
    Report Date
    July 26, 2016
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K123979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 TOMASK 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 THIS INVESTIGATION AND IN COMMUNICATION WITH OUR LOCAL RECALL COORDINATOR, RESMED HAS ISSUED A PRODUCT RECALL NOTIFICATION TO ALL OF OUR AFFECTED CUSTOMERS TO ENSURE THEY ARE FULLY AWARE OF THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A NON-VENTED QUATTRO AIR FULL FACE MASK 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
    475718 QUATTRO AIR FFM MED-AMER VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESMED LTD 62702 1142623

    Patients

    Seq Age Sex Outcome Treatment
    1