BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1019068 · Received March 14, 2008

    Report

    Report Number
    9611451-2008-00106
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 30, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT # 070926 WAS MFG ON 09/26/2007. METHOD - AN INVESTIGATION WILL BE CARRIED OUT ONCE WE RECEIVE THE COMPLAINT DEVICE. RESULTS: NO RESULTS TO DATE. LOT NUMBER 070814: OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. LOT NUMBER 070926: OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. CONCLUSION: NO CONCLUSION CAN BE DONE AT THIS TIME. WE HAVE RECEIVED SIMILAR COMPLAINTS WITH AN OCCURRENCE RATE OF APPROX 0.046% WORLDWIDE FOR THE LAST YR.

    Description of Event or Problem · 1

    A MEDICAL CTR REPORTED TO OUR DISTRIBUTOR, THAT THE MASK SHELL OF RT040L FULL FACE MASK DETACHED TOO EASILY, CAUSING THE PT'S SPO2% TO DECREASE. WHEN LEAK OCCURED, IT PRODUCED BIPAP ALARM-LIKE SOUNDS THAT DISTURBED THE PT AND OTHER STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL FACE MASK MNT FISHER & PAYKEL HEALTHCARE, LTD. RT040L 070814

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention