BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1030344 · Received April 15, 2008

    Report

    Report Number
    9611451-2008-00186
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 8, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED. RESULTS: THE SEAL HAD SEPARATED FROM THE MASK. THIS IS A KNOWN FAILURE MODE. A LOT CHECK HAS REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. THE SEAL IS HELD ON THE MASK BASE BY FRICTION BETWEEN THE SILICONE SEAL AND THE RETAINING SLOT. SEVERAL UNDERCUT BUMP FEATURES PROVIDE SOME MECHANICAL LOCKING. HOWEVER THE SEAL CAN BE PULLED OUT UNDER A FORCE OF APPROXIMATELY 10-15N. THIS 'MECHANICAL LOCKING' HAS BEEN DEEMED TO BE INSUFFICIENT AS COMPLAINTS HAVE BEEN REPORTED DUE TO THE SEAL (CUSHION) COMING OFF DURING USE OR DURING TRANSIT. THE MANUFACTURING PROCESS HAS BEEN UPDATED AND A NEW GLUING PROCESS HAS BEEN ADDED TO PROVIDE BETTER SEAL RETENTION. THE NEW PROCESS HAS COME INTO EFFECT FROM 5 MARCH 2008. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT SHOWS A RATE OF OCCURRENCE OF 0.0531% WORLDWIDE FOR THE PAST YEAR.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY REPORTED TO OUR DISTRIBUTOR THAT THE SEAL OF A FULL FACE MASK HAD SEPARATED FROM THE MASK BASE ON THE REGION OF THE MASK UNDER THE CHIN. THIS WAS REPORTED TO BE AN OUT OF PACKAGE FAILURE. 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. RT040L 071120

    Patients

    Seq Age Sex Outcome Treatment
    1