BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 2955724 · Received February 11, 2013

    Report

    Report Number
    9611451-2013-00088
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 15, 2012
    Report Date
    January 15, 2013
    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

    (B)(4). METHOD: ONE COMPLAINT RT040 MASK WAS RECEIVED FOR INVESTIGATION. THE MASK WAS VISUALLY INSPECTED AND THE PORTS MEASURED. RESULTS: THE HOSPITAL HAS INFORMED US THAT "THE PORT ASSEMBLY ON THE MASK IS INTACT ON THE MASK WHEN IT IS SET UP ON A PATIENT. THE ASSEMBLY AND CAP ARE TIGHTLY CLOSED AND ATTACHED TO MASK." THEY STATED THAT MANY TIMES STAFF RETURNED TO THE PATIENT AND THE ENTIRE ASSEMBLY AND PORT CAP WAS MISSING. VISUAL INSPECTION REVEALED THAT THERE WAS NO DAMAGE TO THE RETURNED MASK, BUT THAT THE PORT CAP WAS MISSING FROM THE LEFT PORT. MEASURING OF THE PORTS REVEALED THAT THEY WERE WITHIN SPECIFICATION FOR THE PRODUCT. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 120828. CONCLUSION: THE OXYGEN PORT CAPS ON THE RT040 MASK ARE DESIGNED TO BE REMOVABLE SO THAT AN OXYGEN LINE CAN BE ATTACHED. THESE PORT CAPS HAVE SUFFICIENT RETENTION TO REMAIN IN PLACE WITH THE PRESSURE INSIDE THE MASK DURING THERAPY. FORCE REQUIRED TO REMOVE THE PORT CAPS ACTUALLY INCREASES WITH AGING. FISHER & PAYKEL HEALTHCARE HAS CONDUCTED EXTENSIVE TESTING ON THE RT040 MASK TO CHECK PORT CAP RETENTION. (B)(4). IT IS POSSIBLE THAT PATIENTS ARE PULLING THE CAPS OFF AND THAT THEY GET LOST IF THEY ARE PULLED OFF COMPLETELY. AS PART OF OUR ONGOING PRODUCT IMPROVEMENT INITIATIVES, THE DESIGN OF THE PORTS WAS ENHANCED TO REMOVE A SOURCE OF AXIAL MOVEMENT OF THE PRESSURE PORT CAP. THIS IMPROVEMENT WAS IMPLEMENTED IN (B)(4) 2011. THE COMPLAINT DEVICES WERE MANUFACTURED AFTER THIS IMPROVEMENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE PORT CAPS ON THE RT040 FULL FACE MASKS WERE POPPING OFF AT LOW PRESSURE AFTER ONE OR TWO DAYS OF PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59459 FULL FACE MASK MNT MNT FISHER & PAYKEL HEALTHCARE LTD RT040 120828

    Patients

    Seq Age Sex Outcome Treatment
    1