BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 2063457 · Received April 19, 2011

    Report

    Report Number
    9611451-2011-00254
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 8, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FISHER & PAYKEL HEALTHCARE HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE REPORTED INCIDENT. WE WILL PROVIDE A FOLLOW-UP REPORT UPON THE RECEIPT OF FURTHER INFORMATION AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MASK IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON FURTHER INFORMATION PROVIDED BY THE HOSPITAL, THE EVENT DESCRIPTION AND OUR KNOWLEDGE OF THE PRODUCT. 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 PRESSURE INSIDE OF THE MASK DURING THERAPY. WITHOUT A COMPLAINT DEVICE WE ARE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. HOWEVER, THE HOSPITAL HAS FURTHER REPORTED THAT THE OXYGEN PORT CAPS CAME OFF AFTER THERAPY BEGAN AND THAT IT WAS "PULLED OFF BY A NURSE OR CONFUSED PATIENT". NO PATIENT CONSEQUENCE WAS REPORTED. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE PRESSURE LINE ADAPTER CAP OF AN RT040 FULL FACE MASK WAS "FALLING OFF " THE MASK. THE HOSPITAL FURTHER REPORTED THAT THE CAP MAY HAVE BEEN "PULLED OFF BY NURSE OR CONFUSED PATIENT". NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE PRESSURE LINE ADAPTER CAP OF AN RT040 FULL FACE MASK FELL WAS "FALLING OFF" THE MASK. THE HOSPITAL FURTHER REPORTED THAT THE CAP MAY HAVE BEEN "PULLED OFF BY NURSE OR CONFUSED PATIENT." NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL FACE MASK MNT MNT FISHER & PAYKEL HEALTHCARE LTD RT040L NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1