BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    END EXPIRATORY FILTER

    MDR report key: 2163021 · Received July 15, 2011

    Report

    Report Number
    9611451-2011-00416
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Report Date
    June 13, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAH
    PMA / PMN Number
    K002839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION AND WITH REGARD TO THIS COMPLAINT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT020 END EXPIRATORY FILTER IS A SINGLE USE PRODUCT DESIGNED TO FIT INTO THE OUTLET PORT OF A VENTILATOR AS A PRECAUTION AGAINST CONTAMINATION BY MICROORGANISMS PRESENT IN THE EXPIRED VENTILATORY GASES OF PATIENTS UNDERGOING TREATMENT. THE TWO COMPLAINT RT020S HAVE NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THE HOSPITAL HAS REPORTED THAT THE COMPLAINT DEVICES HAVE BEEN MISLAID. THE CUSTOMER HAS STATED THAT FILTERS WERE PLACED ON BOTH THE INSPIRATORY AND EXPIRATORY VALVES. THE HOSPITAL FURTHER REPORTED THAT BOTH FILTERS WERE REPLACED WITH THOSE OF A COMPETITOR AND THE PATIENT'S CARBON DIOXIDE LEVELS REDUCED. ATTEMPTS TO OBTAIN FURTHER INFORMATION AND PHOTOGRAPHS WITH REGARD TO THE USE OF NEBULISED DRUGS, EQUIPMENTS USED, SETTINGS AND THE PLACEMENT OF THE FILTERS WERE UNSUCCESSFUL. THE HOSPITAL HAS INDICATED THAT THEY WILL NOT BE PROVIDING ANY FURTHER INFORMATION. WITHOUT FURTHER DETAILED INFORMATION WE ARE UNABLE TO COMMENT ON THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. OUR USER INSTRUCTIONS THAT ACCOMPANY THE DEVICE STATES - "CHANGE EVERY 24 HOURS OR SOONER IF NOTICEABLE DETERIORATION OCCURS, FOLLOWING STANDARD HOSPITAL PROCEDURE." "WHEN NEBULISED DRUGS ARE USED RESISTANCE TO FLOW SHOULD BE MONITORED AND THE PRODUCT REPLACED, FOLLOWING STANDARD HOSPITAL PROCEDURE." "DO NOT SOAK, WASH, STERILISE OR REUSE THIS PRODUCT." OUR USER INSTRUCTIONS ALSO SHOW IN PICTORIAL FORM THAT THE FILTER IS TO BE PLACED BETWEEN THE CONNECTION OF THE VENTILATOR AND THE BREATHING CIRCUIT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO RT020 END EXPIRATORY FILTERS "FAILED" DURING USE AND THAT THE PATIENT'S CARBON DIOXIDE LEVEL ROSENO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO RT020 END EXPIRATORY FILTERS "FAILED" DURING USE AND THAT THE PATIENT'S CARBON DIOXIDE LEVELS ROSE NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 END EXPIRATORY FILTER CAH CAH FISHER & PAYKEL HEALTHCARE LTD RT020 110303

    Patients

    Seq Age Sex Outcome Treatment
    1