BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1030339 · Received April 15, 2008

    Report

    Report Number
    9611451-2008-00171
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: AN INVESTIGATION WAS CONDUCTED ON THE RETURNED UNIT. RESULTS: THE DEVICE WAS BROKEN AT THE NOSE BRIDGE. CONCLUSION: STRENGTH TESTING OF THE FOREHEAD PIECE HAS SHOWN THAT IT TAKES AN AVERAGE FORCE OF 63.7 N (6.4KG) FOR STRESS MARKS TO APPEAR AND AN AVERAGE FORCE OF 82.6 N (8.4KG) FOR FAILURE TO OCCUR. IT TAKES AN EXCESSIVE FORCE ON THE FOREHEAD REST FOR FAILURE. THE CAUSE OF THE FAILURE WAS THE APPLICATION OF EXCESSIVE FORCE, BUT IT IS NOT POSSIBLE TO DETERMINE THE SOURCE AND AMOUNT OF THE FORCE THAT CAUSED THIS FAILURE. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT SHOWS A RATE OF OCCURRENCE OF 0.0004% WORLDWIDE FOR THE PAST YEAR.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY REPORTED TO OUR DISTRIBUTOR THAT THERE WAS A BREAK IN THE PLASTIC AT THE NASAL BRIDGE OF AN RT040 FULL FACE MASK. 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. RT040L 071115

    Patients

    Seq Age Sex Outcome Treatment
    1