BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIRAGE ACTIVA LT MASK MED-AMER

    MDR report key: 1525955 · Received November 6, 2009

    Report

    Report Number
    3004604967-2009-00026
    Event Type
    Other
    Date Received
    November 6, 2009
    Date of Event
    October 2, 2009
    Report Date
    November 6, 2009
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K032916
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2009, THE COMPLAINT PRODUCT WAS RECEIVED AT RESMED CORP LOCATED IN (B)(4). A PRELIMINARY INSPECTION WAS PERFORMED WITH NO DEFECTS OBSERVED. THE MASK SYSTEM WAS SENT TO THE DESIGN FACILITY LOCATED IN (B)(4) FOR A FURTHER EVAL. THE DESIGN FACILITY EVALUATED THE MASK SYSTEM AND CONFIRMED THE MASK WAS BUILT TO THE DESIGN SPECS WITH NO ABNORMALITIES OBSERVED. THE CLINICAL OPINION PROVIDED BY RESMED'S MEDICAL DIRECTOR CONCLUDED "THE SYMPTOMS WERE CAUSED BY POSITIVE PRESSURE FROM THE DEVICE CAUSING DISTENSION OF THE EARDRUM. IF THERE IS SOME MALFUNCTION OF THE EUSTACHIAN TUBE, (GENERALLY DUE TO MINOR SWELLING OF THE MUCOSA), THEN AIR MAY BE TRAPPED UNDER PRESSURE IN THE INNER EAR CAUSING PAIN. THE GAS IS RESORBED AFTER A FEW HOURS WITH COMPLETE RESOLUTION OF SYMPTOMS. " BASED ON THIS CONCLUSION AND THE EXAMINATION OF THE DEVICE, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A PT WEARING A RESMED CPAP MASK REPORTED THEY AWOKE TO A BURNING SENSATION IN THEIR INNER EAR THAT WAS FOLLOWED BY A TEMPORARY HEARING IMPAIRMENT FOR APPROX 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGE ACTIVA LT MASK MED-AMER MIRAGE ACTIVA LT BZD RESMED LTD. 60148

    Patients

    Seq Age Sex Outcome Treatment
    1