BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1056678 · Received March 28, 2008

    Report

    Report Number
    9611451-2008-00133
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBERS ARE 071114, 071025 AND 070226 AND MFG DATES ARE 11/14/2007, 10/25/2007 AND 2/26/2007, RESPECTIVELY. THE INVESTIGATION WAS CONDUCTED BASED ON THE RETURNED MASKS, EVENT DESCRIPTION AND PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: THE SEALS WERE HELD TO THE MASK BASES BY FRICTION. THE FRICTION APPLIED WAS NOT SUFFICIENT ENOUGH TO HOLD THE SEALS TO THE BASES OF THE MASKS. LOT NUMBER 071109: OUR RECORDS INDICATE THAT TWO COMPLAINTS OF THIS NATURE HAVE BEEN RECEIVED FOR THE GIVEN LOT NUMBER. LOT NUMBER 071114: OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. LOT NUMBER 071025: OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. LOT NUMBER 070226: OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. CONCLUSION: WE HAVE AN OPEN CAPA PROJECT TO ADDRESS THIS ISSUE AND TO IMPLEMENT POTENTIAL DESIGN SOLUTIONS WE HAVE DEVELOPED TO PREVENT SEPARATION ISSUES OCCURRING IN THE FUTURE. WE ARE CURRENTLY IMPLEMENTING AN ADDED SILICONE ADHESIVE STEP (THE APPLICATION OF AN ADHESIVE BETWEEN THE SILICONE FACIAL SEAL AND THE PLASTIC MASK BASE) IN OUR PRODUCTION PROCESS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY REPORTED TO OUR DISTRIBUTOR THAT 6 SEALS OF RT040M FULL FACE MASKS HAD SEPARATED FROM THE MASK BASES PRIOR TO THE OPENING OF THE PACKAGE. 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 071109

    Patients

    Seq Age Sex Outcome Treatment
    1