BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPITAL FULL FACE MASK VENTED

    MDR report key: 4120167 · Received September 25, 2014

    Report

    Report Number
    9611451-2014-00784
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Report Date
    September 4, 2014
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICES WERE NOT AVAILABLE FOR INVESTIGATION. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS AND OUR KNOWLEDGE OF THE PRODUCT. ONE OF THE COMPLAINT DEVICES WAS FROM LOT 140508 (DATE OF MANUFACTURE: 8 MAY 2014). RESULTS: THE HOSPITAL FURTHER REPORTED THAT THE PATIENTS WERE RESTLESS WHILE USING THE RT040 VENTED HOSPITAL FULL FACE MASKS. THEY ALSO MENTIONED THAT THE PATIENTS WERE UNCOMFORTABLE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 140612 AND 140508. 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 THE PRESSURE INSIDE THE MASK DURING THERAPY. WITHOUT THE RETURN OF THE COMPLIANT DEVICES, WE ARE UNABLE TO DETERMINE IF THE PORT CAPS OR PORTS WERE OUT OF SPECIFICATION OR DAMAGED. HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL IT IS POSSIBLE THAT THE PATIENTS WERE PULLING THE CAPS OFF FROM THE MASK AND THEY MAY BE LOST IF THEY ARE COMPLETELY DETACHED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE PORT CAPS ON TWO RT040 VENTED HOSPITAL FULL FACE MASK WERE FALLING OFF. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599039 HOSPITAL FULL FACE MASK VENTED MNT MNT FISHER & PAYKEL HEALTHCARE LTD RT040 140612

    Patients

    Seq Age Sex Outcome Treatment
    1