BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 2042764 · Received April 7, 2011

    Report

    Report Number
    9611451-2011-00222
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Report Date
    March 8, 2011
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).FISHER & PAYKEL HEALTHCARE HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE REPORTED INCIDENT.WE WILL PROVIDE A FOLLOW-UP REPORT UPON THE RECEIPT OF FURTHER INFORMATION AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONE COMPLAINT MASK WAS RETURNED AND VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED THE PORT CAP OF THE RETURNED COMPLAINT MASK WAS MISSING AND NO DAMAGE WAS OBSERVED ON THE PORT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101110. A LOT CHECK COULD NOT BE PERFORMED FOR THE OTHER FOUR COMPLAINT MASKS AS NO LOT NUMBER WAS PROVIDED. 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 PRESSURE INSIDE OF THE MASK DURING THERAPY. NO DAMAGE WAS OBSERVED ON THE PORT OF THE RETURNED MASK AND THE HOSPITAL HAS FURTHER REPORTED THAT IT IS LIKELY HOSPITAL STAFF OR PATIENT'S ACCIDENTALLY REMOVE THE PORT CAPS WHEN REMOVING THE MASKS. THE HOSPITAL HAS ALSO REPORTED THAT THERE HAS BEEN NO PATIENT CONSEQUENCE. OUR MONITORING AND TRENDING OF PORT CAPS COMING LOOSE HAS A RATE OF OCCURRENCE OF (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE OXYGEN PORT ON THE RT040 FULL FACE MASK CAME OFF DURING THERAPY. THE HOSPITAL HAS FURTHER REPORTED THAT "THE PATIENTS MAY HAVE REMOVED THEM ACCIDENTLY WHILE REMOVING THE MASK FOR REST" AND THAT THERE WAS NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT OXYGEN PORTS ON FIVE RT040 FULL FACE MASKS CAME OFF DURING THERAPY. THE HOSPITAL HAS FURTHER REPORTED THAT "THE PATIENTS MAY HAVE REMOVED THEM ACCIDENTLY WHILE REMOVING THE MASK FOR REST" AND THAT THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL FACE MASK MNT MNT FISHER & PAYKEL HEALTHCARE LTD RT040M 101110

    Patients

    Seq Age Sex Outcome Treatment
    1