BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1035547 · Received April 29, 2008

    Report

    Report Number
    9611451-2008-00251
    Event Type
    Malfunction
    Date Received
    April 29, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 14, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ARE EN ROUTE TO THE MFR. THE LOT NUMBERS INVOLVED WERE: 071207, 071026, 071204, AND 071017. THE MFR DATES WERE: 12/07/2007, 10/26/2007, 12/04/2007 AND 10/17/2007. AN INVESTIGATION WAS CONDUCTED BASED ON THE EVENT DESCRIPTION AND PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. 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 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 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 APPROXIMATELY 0.117% WORLDWIDE FOR THE PAST YEAR.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED TO OUR DISTRIBUTOR THAT THE MASK CUSHION OF A QUANTITY OF 28 RT040M FULL FACE MASKS SEPARATED FROM THE BACKPLATE (I.E. THE MASK BASE) DURING USE. 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