BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 2240096 · Received September 9, 2011

    Report

    Report Number
    9611451-2011-00553
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 12, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT DATE AND DEVICE MANUFACTURER DATE - 090807 - 08/07/2009; 100618 - 06/18/2010. EIGHTEEN COMPLAINT MASKS WERE RETURNED, 14 HAD LOT 090807 AND 3 HAD LOT 100618. THE RETURNED COMPLAINT MASKS WERE VISUALLY INSPECTED. THE VISUAL INSPECTION REVEALED THAT THE ON 10 OF THE RETURNED COMPLAINT MASKS THE SEAL IS PARTLY SEPARATED FROM THE MASK BASE STARTING NEAR THE CHIN. THE MASK SEAL FOR THE OTHER 3 COMPLAINT MASKS THE MASK SEAL HAS COMPLETELY SEPARATED FROM THE MASK BASE. THE VISUAL INSPECTION OF ALL COMPLAINT MASKS REVEALED THAT THE SEAL WAS GLUED PROPERLY WITH A CONTINUOUS BEAD OF GLUE. INDENTS IN THE GLUE LINE SHOW THAT THE SEAL WAS PROPERLY INSERTED INTO THE BASES. A LOT CHECK REVEALED (B)(4) OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 090807 A LOT CHECK REVEALED (B)(4) OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 100618 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. THE VISUAL INSPECTION OF THE RETURNED DEVICES SHOW 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 DUE TO ADVERSE EFFECTS OF TRANSPORT OR STORAGE CONDITIONS. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE MASK SEALS OF THE RT040 FULL FACE MASK SEPARATED FROM THE SHELL CAUSING IT TO LEAK. 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 LTD RT040 SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1