BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1078020 · Received July 16, 2008

    Report

    Report Number
    9611451-2008-00438
    Event Type
    Malfunction
    Date Received
    July 16, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE LOT NUMBERS CONCERNED ARE 071210 AND 071219 WITH CORRESPONDING MANUFACTURE DATES BEING 12/2007 FOR BOTH LOT NUMBERS. A LOT CHECK HAS REVEALED 1 OTHER COMPLAINT FOR THESE LOT NUMBERS. METHOD: THE RT040M MASKS ARE EN ROUTE TO THE MFR FOR INVESTIGATION. PENDING RECEIPT OF THE MASKS AND ANALYSIS OF THE ALLEGED MALFUNCTION, WE ARE UNABLE TO COMMENT ON THIS COMPLAINT SPECIFICALLY. HOWEVER, WE HAVE PREVIOUSLY RECEIVED SIMILAR COMPLAINTS IN RESPECT OF THIS DEVICE. RESULT: THERE IS A KNOWN FAILURE MODE. THE SEAL IS HELD ON THE MASK BASE BY FRICTION BETWEEN THE SILICONE SEAL AND THE RETAINING SLOT. SEVERAL UNDERCUT BUMP FEATURES CAN PROVIDE SOME MECHANICAL LOCKING. HOWEVER, THE SEAL CAN BE PULLED OUT UNDER A FORCE OF APPROX 10-15N. THIS "MECHANICAL LOCKING" HAS BEEN DEEMED TO BE INSUFFICIENT AS COMPLAINTS HAVE BEEN REPORTED DUE TO THE SEAL (OR CUSHION) COMING OFF DURING USE OR DURING TRANSIT. CONCLUSION: THE MFG PROCESS HAS BEEN UPDATED AND A NEW GLUING PROCESS HAS BEEN ADDED TO PROVIDE BETTER SEAL RETENTION. THE NEW PROCESS CAME INTO EFFECT FROM 5 MARCH 2008. THE RT040 MASKS SPECIFIC TO THIS COMPLAINT WERE MANUFACTURED PRIOR TO THIS DATE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY (B) (6) REPORTED TO OUR DISTRIBUTOR THAT THE FACIAL SEAL OF 5 UNITS OF THE RT040M FULL FACE MASK FELL APART FROM THE MASK BASE. THIS WAS DETECTED WHILE THE PRODUCT WAS STILL IN PACKAGING. NO PT CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1