BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT FX MASK SYSTEM - AMER

    MDR report key: 2390689 · Received December 16, 2011

    Report

    Report Number
    3004604967-2011-00059
    Event Type
    Injury
    Date Received
    December 16, 2011
    Date of Event
    November 1, 2011
    Report Date
    December 16, 2011
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K090244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED TO THE EMERGENCY ROOM BECAUSE HE COULD NOT BREATHE. AFTER EVAL FROM THE DOCTOR, IT WAS DETERMINED THE PT SUFFERED A STROKE DUE TO LACK OF OXYGEN. THE DOCTOR HAD NOTICED THE SOFT MATERIAL FROM THE SWIFT FX NASAL PILLOW. THE DOCTOR STATED THAT THE POTENTIAL COLLAPSE OF THE SOFT PILLOWS MAY OCCLUDE THE PT'S AIRWAY AND MAY HAVE CONTRIBUTED TO THE EVENT. THE MASK WAS RECEIVED AT RESMED CORP. A PRELIMINARY EVAL WAS CONDUCTED AND THERE WERE NO DEFORMATIONS OBSERVED WITH THE PILLOWS THAT ENGAGE WITH THE NASAL PASSAGES. THE FLEXIBLE CUSHION IS DESIGNED TO BE SOFT AND TO CONFORM TO THE FACE, WITH LOCATION AND STABILITY ASSISTED BY THE PILLOWS ENGAGING IN THE NOSE (THE 'PEGS IN HOLES' APPROACH). THE STIFFNESS OF THE PILLOWS IS DESIGNED TO MAINTAIN COMFORT WHILST DELIVERING EFFECTIVE THERAPY. THE MASK HAS BEEN FORWARDED TO RESMED LTD FOR AN ENGINEERING INVESTIGATION.

    Description of Event or Problem · 1

    RESMED WAS MADE AWARE OF A PT THAT SUFFERED A STROKE WHILE ON CPAP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT FX MASK SYSTEM - AMER BZD RESMED LTD. 61500

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other