BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 2021261 · Received March 17, 2011

    Report

    Report Number
    9611451-2011-00168
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OUR INVESTIGATION INTO THE REPORTED ISSUE IS CURRENTLY IN PROGRESS. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT040 FULL FACE MASK WAS NOT RETURNED TO FPH (B)(4) FOR INSPECTION. AN ATTEMPT WAS MADE TO OBTAIN FURTHER INFORMATION ABOUT THE REPORTED COMPLAINT, HOWEVER, NO RESPONSE WAS RECEIVED FROM THE HOSPITAL. 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 PRESSURE INSIDE OF THE MASK DURING THERAPY. WITHOUT THE COMPLAINT DEVICE OR ADDITIONAL INFORMATION REGARDING THE SET-UP, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAULT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THEY EXPERIENCING A GENERAL PROBLEM WHERE THE PORT CAPS ON RT040 FULL FACE MASKS FALL OFF. NO PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THEY EXPERIENCING A GENERAL PROBLEM WHERE THE PORT CAPS ON RT040 FULL FACE MASKS FALL OFF. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL FACE MASK MNT MNT FISHER & PAYKEL HEALTHCARE LIMITED RT040 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1