BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-VENTED HOSPITAL FULL FACE MASK

    MDR report key: 5845780 · Received August 4, 2016

    Report

    Report Number
    9611451-2016-00393
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Report Date
    July 8, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT041S NON-VENTED HOSPITAL FULL FACE MASKS (ONE IN AN UNSEALED AND SIX IN SEALED PACKAGING BAGS) WERE RETURNED TO FPH IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE MASK IN AN UNSEALED PACKAGING BAG REVEALED THAT THE SEAL WAS PARTLY SEPARATED FROM THE MASK BASE. HOWEVER, A CONTINUOUS BEAD OF GLUE WAS FOUND AROUND THE MASK SEAL. FURTHER INSPECTION REVEALED THAT THE SEAL HAD BEEN PROPERLY INSERTED IN THE MASK BASE DURING MANUFACTURE. NO FAULT WAS FOUND WITH THE SIX MASKS IN SEALED PACKAGING BAGS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150817. CONCLUSION: WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE OBSERVED SEPARATION. VISUAL INSPECTION INDICATED THAT THE MASK WAS ASSEMBLED AND GLUED PROPERLY. THIS SUGGESTS THAT THE SEPARATION OCCURRED POST PRODUCTION. THE RT041 FULL FACE MASK FEATURES A MASK BASE, SEAL, AND HEADGEAR. THE MASK SEAL IS INSERTED INTO THE MASK BASE AND IS SECURED WITH GLUE. EACH ASSEMBLED MASK SEAL IS INSPECTED TO ENSURE IT IS CORRECTLY INSERTED AND THERE ARE NO UNACCEPTABLE GAPS BETWEEN THE SEAL AND THE BASE. SAMPLES ARE TAKEN AND THE MASK SEALS ARE PULLED APART AFTER 24 HOURS TO ENSURE THEY MEET OR EXCEED THE REQUIRED DETACHMENT FORCE BEFORE THE ASSEMBLED PRODUCT CAN BE RELEASED. OUR USER INSTRUCTIONS ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF THE RT041S NON-VENTED HOSPITAL FULL FACE MASK. IT ALSO STATE THE FOLLOWING: "OPERATING PRESSURE RANGE: 5 - 25 CMH2O"; "THIS MASK MAY ONLY BE USED IN A HOSPITAL OR CLINICAL SETTING WHERE THE PATIENT IS ADEQUATELY MONITORED BY TRAINED MEDICAL STAFF. FAILURE TO MONITOR THE PATIENT MAY RESULT IN LOSS OF THERAPY, SERIOUS INJURY OR DEATH."; "IN THE CASE OF THERAPY DEVICE FAILURE, THE USE OF THIS MASK REQUIRES THE SAME LEVEL OF ATTENTION AND ASSISTANCE AS IN THE USE OF A TRACHEAL TUBE."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT041S NON-VENTED HOSPITAL FULL FACE MASK WAS POPPING OFF WHILE BEING USED WITH A VENTILATOR. IT SEEMED THAT THE MASK WAS LOSING ITS SEAL ON A FLOW OF APPROXIMATELY 30 L/MIN. THIS WAS NOTICED DURING USE ON A PATIENT; HOWEVER, NO PATIENT CONSEQUENCE WAS REPORTED. THE HOSPITAL ALSO STATED THAT THE REPORTED INCIDENT WAS OBSERVED ON NINE OTHER RT041S NON-VENTED HOSPITAL FULL FACE MASKS FOR TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499661 NON-VENTED HOSPITAL FULL FACE MASK MNT MNT FISHER & PAYKEL HEALTHCARE LIMITED RT041S 150817

    Patients

    Seq Age Sex Outcome Treatment
    1