BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MNT

    MDR report key: 901613 · Received August 22, 2007

    Report

    Report Number
    9611451-2007-00307
    Event Type
    Malfunction
    Date Received
    August 22, 2007
    Report Date
    July 24, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. RESULTS- ONE POTENTIAL CONTRIBUTING FACTOR MAY BE DUE TO IMPROPER FITTING OF THE RT040 FULL FACE MASK ONTO THE PATIENT. THE RT040 MASK IS NEW TO THE MARKET AND MANY USERS ARE IN THE PROCESS OF CONVERTING FROM AN EXISTING COMPETITORS MASK TO THE RT040, AND MAY NOT BE FAMILIAR WITH THE SIZING AND FITTING OF THIS NEW MASK. HOWEVER, WE ARE LOOKING AT WAYS TO IMPROVE SEAL RETENTION IN THE RT040 MASK. CONCLUSIONS- FISHER AND PAYKEL HEALTHCARE MARKETING HAS DEVELOPED AN IMPROVED IN-SERVICE PROGRAM TO ADDRESS THE POTENTIAL FOR IMPROPER FITTING. THIS PROGRAM IS CURRENTLY BEING IMPLEMENTED FOR THE CUSTOMERS IN THE UNITED STATES. WE HAVE RECEIVED SIMILAR COMPLAINTS AND WE ARE CURRENTLY TRENDING THIS AT AN OCCURRENCE RATE OF APPROXIMATELY 0.046%. WE HAVE AN OPEN CAPA PROJECT TO ADDRESS THIS ISSUE AND TO IMPLEMENT POTENTIAL DESIGN SOLUTIONS TO PREVENT RECURRENCE IN THE FUTURE.

    Description of Event or Problem · 1

    A HOSPITAL IN ROCKFORD REPORTED THAT THE RT040 MASK FALLS APART. WE'VE TAKEN THIS TO MEAN THAT THE MASK SEAL DETACHES FROM THE MASK SHELL. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MNT MNT FISHER & PAYKEL HEALTHCARE, LTD. RT040

    Patients

    Seq Age Sex Outcome Treatment
    1 YR