BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1031413 · Received April 18, 2008

    Report

    Report Number
    9611451-2008-00184
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K06004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EN ROUTE TO THE MFR. THE INVESTIGATION WAS CONDUCTED BASED ON THE EVENT DESCRIPTION AND PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. A LOT CHECK HAS REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. 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. CONCLUSIONS: FISHER & PAYKEL HEALTHCARE HAS IMPLEMENTED AN IN-SERVICE EDUCATION PROGRAM TO FURTHER ENSURE THAT HEALTHCARE PRACTITIONERS FULLY UNDERSTAND THE PROPER FITTING OF THE RT040 MASK. THIS PROGRAMME HAS BEEN AND CONTINUES TO BE ROLLED OUT TO CUSTOMERS IN THE UNITED STATES. IN ADDITION, WE HAVE INTRODUCED AN ADDITIONAL 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 RECEIVED SIMILAR COMPLAINTS AND ARE CURRENTLY TRENDING THIS AT AN OCCURRENCE RATE OF APPROX 0.0531% WORLDWIDE FOR THE PAST YEAR.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY REPORTED TO OUR DISTRIBUTOR THAT THE MASK SEAL UNDER THE CHIN ON AN RT040M FULL FACE MASK SEPARATED FROM THE INTERFACE MOLD AND COULD NOT BE PUT BACK TOGETHER FOR USE. THIS WAS REPORTED TO BE OUT OF PACKAGE FAILURE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1