BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 2244662 · Received September 13, 2011

    Report

    Report Number
    9611451-2011-00559
    Event Type
    Malfunction
    Date Received
    September 13, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 18, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED RT040M FULL FACE MASKS WERE VISUALLY INSPECTED FOR SEAL SEPARATION. RESULTS: VISUAL INSPECTION OF THE RETURNED MASKS REVEALED THAT THE SEALS WERE COMPLETELY SEPARATED FROM THE BASES, CONFIRMING THE REPORTED FAULT. FURTHER INSPECTION SHOWED THAT THE SEALS WERE GLUED PROPERLY WITH A CONTINUOUS BEAD OF GLUE. INDENTS IN THE GLUE LINE SHOW THAT THE SEAL WAS PROPERLY INSERTED INTO THE BASE. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 090807. CONCLUSION: THE RT040 FULL FACE MASK FEATURES A MASK BASE, SEAL AND HEADGEAR. THE MASK SEAL IS INSERTED INTO THE MASK BASE AND IS SECURED WITH GLUE. THE RT040 MASK IS SUBJECTED TO POST-PRODUCTION TESTS TO ENSURE THE SEAL ON THE MASK CAN WITHSTAND A REMOVAL FORCE GREATER THAN 100N. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE SEPARATION. VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE MASK WAS ASSEMBLED AND GLUED PROPERLY. THIS SUGGESTS THAT THE SEPARATION OCCURRED POST-PRODUCTION, POSSIBLY DUE TO THE DRYING OUT OR SEPARATION OF THE GLUE CAUSED BY ADVERSE CONDITIONS DURING TRANSPORT OR STORAGE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE SILICONE SEALS OF TWO RT040M FULL FACE MASKS WERE FOUND SEPARATED FROM THE MASK BASES, CAUSING IT TO LEAK. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL FACE MASK MNT MNT FISHER & PAYKEL HEALTHCARE LIMITED RT040M 090807

    Patients

    Seq Age Sex Outcome Treatment
    1