BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1052577 · Received May 22, 2008

    Report

    Report Number
    9611451-2008-00311
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS NOT RETURNED TO THE MFR. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND PREVIOUS EXPERIENCE WITH SIMILAR COMPLAINTS. RESULTS: THE IMPROPER FITTING OF THE MASK MAY HAVE CONTRIBUTED TO THE SILICONE SEAL SEPARATING FROM THE BASE OF THE MASK. THE RT040 MASK IS RELATIVELY NEW TO THE MARKET AND MANY USERS HAVE BEEN CONVERTING FROM A PREVIOUSLY USED COMPETITOR'S DEVICE TO THE RT040 AND AS A RESULT MAY NOT BE PROFICIENT WITH THE SIZING AND FITTING OF THE RT040. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSIONS: FISHER AND PYKEL HEALTHCARE HAS IMPLEMENTED AN IN-SERVICE EDUCATION PROGRAM TO FURTHER ENSURE THAT HEALTHCARE PRACTITIONERS FULLY UNDERSTAND THE PROPER FITTING OF THE RT040 MASK. THIS PROGRAM HAS BEEN AND CONTINUES TO BE ROLLED OUT TO CUSTOMERS IN THE UNITED STATES. IN ADDITION, WE HAVE INTRODUCED AN ADDITIONAL SILICONE ADHEXISVE STEP (TO APPLY ADHESIVE BETWEEN THE SILICONE FACIAL SEAL LAND THE PLASTIC MASK BASE) IN OUR MFG, PROCESS WHICH IS AIMED AT REDUCING THE POTENTIAL FOR SEPARATION TO OCCUR. WE HAVE RECEIVED SIMILAR COMPLAINTS AND ARE CURRENTLY TRENDING THIS AT AN OCCURRENCE RATE OF APPROX 0.1002% WORLDWIDE FOR THE PAST YEAR.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN PENNSYLVANIA REPORTED THROUGH OUR DISTRIBUTOR THAT THE SEAL OF AN RT040L FULL FACE MASK WAS DETACHING FROM THE FRAME (I.E. MASK BASE). NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL FACE MASK MNT FISHER & PAYKEL HEALTHCARE, LTD. RT040L 071129

    Patients

    Seq Age Sex Outcome Treatment
    1