BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1063705 · Received June 20, 2008

    Report

    Report Number
    9611451-2008-00388
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBERS CONCERNED ARE 080211, 080215, 071109 AND 071213 WITH CORRESPONDING MANUFACTURE DATES BEING 02/2008, 02/2008, 11/2007 AND 12/2007 RESPECTIVELY. A LOT CHECK HAS REVEALED 3 OTHER COMPLAINTS FOR THESE LOT NUMBERS. THE RT040M MASKS ARE EN ROUTE TO THE MANUFACTURER FOR INVESTIGATION. PENDING RECEIPT OF THE MASKS AND ANALYSIS OF THE ALLEGED MALFUNCTION, WE ARE UNABLE TO COMMENT ON THIS COMPLAINT SPECIFICALLY. HOWEVER, WE HAVE PREVIOUSLY RECEIVED SIMILAR COMPLAINTS IN RESPECT OF THIS DEVICE. RESULT: 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. CONCLUSION: 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 & 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 PROGRAM 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 MANUFACTURING 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 APPROXIMATELY 0.99% WORLDWIDE FOR THE PAST YEAR.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY, REPORTED TO OUR DISTRIBUTOR THAT THE FACIAL SEAL OF 60 UNITS OF THE RT040M FULL FACE MASK FELL APART FROM THE MASK BASE. NO PATIENT 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