BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1134444 · Received August 21, 2008

    Report

    Report Number
    9611451-2008-00493
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Report Date
    July 22, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT DATES INVOLVED WITH THIS COMPLAINT WERE: 080116, 080218 AND 071212. THE MANUFACTURE DATES OF THE DEVICES WERE: 01/16/2008, 02/18/2008 AND 12/12/2007. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION WAS CONDUCTED BASED ON THE EVENT DESCRIPTION AND PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: THE SILICONE SEAL THAT ATTACHES TO THE PLASTIC BASED OF THE MASK IS KNOWN TO SEPARATE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE LOT NUMBERS REPORTED IN THIS COMPLAINT. CONCLUSION: THE SEAL IS HELD TO THE MASK BASE BY FRICTION IN THE RETAINING SLOTS. THIS HAS NOT ALWAYS BEEN INSUFFICIENT TO HOLD THE SEAL IN PLACE. WE HAVE INTRODUCED AN ADDITIONAL SILICONE ADHESIVE STEP (TO APPLY ADHESIVE BETWEEN THE SILICONE FACIAL SEAL AND THE PLASTIC MASK BASE) IN OUR MANUFACTURING PROCESS WHICH IS AIMED AT REDUCING THE POTENTIAL FOR SEPARATION TO OCCUR. OUR MONITORING AND TRENDING OF DETACHED MASK SEALS WORLDWIDE FOR THE LAST YEAR TO THE END OF 2008 HAS A RATE OF OCCURRENCE OF 0.0877%.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED, THAT ON A QUANTITY OF 14 RT040M FULL FACE MASKS, THE SEAL IN THE MASK WAS COMING LOOSE OR COMPLETELY REMOVING WHEN ON A PATIENT. NO PATIENT 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