BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1060010 · Received June 11, 2008

    Report

    Report Number
    9611451-2008-00335
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Report Date
    May 13, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MFR. AN INVESTIGATION WAS THEREFORE CONDUCTED BASED ON THE EVENT DESCRIPTION AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS. RESULTS: A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. THE SILICONE SEAL IS HELD IN PLACE IN THE BASE OF THE MASK BY AN INTERFERENCE FIT. THE IMPROPER FITTING OF THE MASK MAY HAVE CONTRIBUTED TO THE SILICONE SEAL SEPARATING FROM THE BASE OF THE MASK. CONCLUSIONS: 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. FISHER & PLAYKEL HEALTHCARE HAS IMPLEMENTED AN IN-SERVICE EDUCATION PROGRAM TO FURTHER ENSURE THAT HEALTHCARE PRACTITIONERS FULLY UNDERSTAND THE PROPER FITTING OF THE RT040 MASK. THIS PROBLEM HAS BEEN AND CONTINUES TO BE ROLLED OUT TO CUSTOMERS IN THE UNITED STATES. IN ADDITION, WE HAVE INTRODUCED AN ADD'L SILICONE ADHESIVE STEP (TO APPLY ADHESIVE BETWEEN THE SILICONE FACIAL SEAL AND THE PLASTIC MASK BASE) IN OUR MFG PROCESS WHICH IS AIMED AT REDUCING THE POTENTIAL FOR SEPARATION TO OCCUR. WE HAVE REC'D SIMILAR COMPLAINTS AND ARE CURRENTLY TRENDING THIS AT AN OCCURRENCE RATE OF APPROX 0.10% WORLDWIDE FOR THE PAST YEAR.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN SOUTH DAKOTA REPORTED TO OUR DISTRIBUTOR THAT THE FACIAL SEAL OF THE RT040M FULL FACE MASK CAME OFF THE MASK BASE, WHILE BEING USED ON A PT. 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. RT040M 080215

    Patients

    Seq Age Sex Outcome Treatment
    1