BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1071372 · Received July 8, 2008

    Report

    Report Number
    9611451-2008-00419
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    April 9, 2008
    Report Date
    May 19, 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

    AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS, AS THE COMPLAINT DEVICE HAD NOT BEEN RETURNED FOR INVESTIGATION. RESULTS - THIS IS A KNOWN FAILURE MODE. 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 APPROX 10-15N. THIS "MECHANICAL LOCKING" HAS BEEN DEEMED TO BE INSUFFICIENT AS COMPLAINTS HAVE BEEN REPORTED DUE TO THE SEAL (OR CUSHION) COMING OFF DURING USE OR DURING TRANSIT. THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. CONCLUSION - THE MANUFACTURING PROCESS HAS BEEN UPDATED AND A NEW GLUING PROCESS HAS BEEN ADDED TO PROVIDE BETTER SEAL RETENTION. THE NEW PROCESS CAME INTO EFFECT FROM 2008. OUR MONITORING AND TRENDING FOR FULL FACE MASK DETACHED SEAL HAS A RATE OF OCCURRENCE OF 0.89% WORLDWIDE FOR THE LAST YEAR.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT THE CUSHION OF A FULL FACE MASK FELL APART. 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. RT040S 071009

    Patients

    Seq Age Sex Outcome Treatment
    1