BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPITAL FULL FACE MASK WITH EXHALATION VENTS

    MDR report key: 1004704 · Received March 3, 2008

    Report

    Report Number
    9611451-2008-00074
    Event Type
    Malfunction
    Date Received
    March 3, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EN ROUTE TO THE MFR. ADDITIONAL LOT IS 071011. ADDITIONAL MANUFACTURER DATE IS 10/11/2007. THE DEVICE IS NOT YET AVAILABLE TO EVALUATE, HOWEVER, AN EVALUATION IS MADE FROM THE EVENT DESCRIPTION AND PREVIOUS EXPERIENCE. FROM THE EVENT DESCRIPTION, THIS APPEARS CONSISTENT WITH THE SITUATION WE ARE AWARE OF WHERE SEALS CAN DETACH FROM THE BASE OF THE MASK. OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBERS. CONCLUSION: WE HAVE AN OPEN CAPA PROJECT TO ADDRESS THIS ISSUE AND TO IMPLEMENT POTENTIAL DESIGN SOLUTIONS TO PREVENT RECURRENCE IN THE FUTURE. WE CURRENTLY ANTICIPATE THAT WE WILL BE IMPLEMENTING AN ADDED SILICONE ADHESIVE STEP TO APPLY THE ADHESIVE BETWEEN THE SILICONE FACIAL SEAL AND THE PLASTIC MASK BASE IN OUR PRODUCTION PROCESS IMMINENTLY. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.045 %.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED VIA OUR DISTRIBUTOR THAT THE SEAL OF A RT040S FULL FACE MASK HAD SEPARATED FROM THE PLASTIC SHELL PRIOR TO THE PACKAGE BEING OPENED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPITAL FULL FACE MASK WITH EXHALATION VENTS MNT FISHER & PAYKEL HEALTHCARE, LTD. RT040S 071009

    Patients

    Seq Age Sex Outcome Treatment
    1