BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2003228 · Received February 28, 2011

    Report

    Report Number
    9611451-2011-00103
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 29, 2011
    Report Date
    February 1, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290V CHAMBER WAS VISUALLY INSPECTED FOR DAMAGE AND WAS CONNECTED TO A WATERBAG FOR FUNCTIONAL TESTING. RESULTS: THE CHAMBER FILLED NORMALLY WHEN CONNECTED TO A WATERBAG; HOWEVER, ONCE THE CHAMBER HAD FILLED, SMALL DROPS OF WATER WERE OBSERVED LEAKING FROM THE CONNECTION BETWEEN THE FEEDSET TUBE AND WATERBAG SPIKE. INSPECTION SHOWED THAT GLUE HAD BEEN APPLIED TO THE TUBING PROPERLY AND PROVIDED FULL COVERAGE AROUND THE TUBE; HOWEVER IT APPEARED THAT THE GLUE HAD NOT SEALED COMPLETELY INSIDE OF THE WATERBAG SPIKE, CAUSING IT TO LEAK. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 101008. CONCLUSION: ALL CHAMBERS ARE PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THE REPORTED LEAK IS LIKELY DUE TO THE GLUE THAT HAD NOT SEALED COMPLETELY INSIDE THE WATERBAG SPIKE. OUR USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE WATER FEEDSET OF TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE DEFECTIVE. IT WAS FURTHER REPORTED THAT THE WATER LEAKED FROM THE FEEDSET LINE. THIS WAS OBSERVED BEFORE USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE WATER FEEDSET OF TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE DEFECTIVE. IT WAS FURTHER REPORTED THAT THE WATER LEAKED FROM THE FEEDSET LINE. THIS WAS OBSERVED BEFORE USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V

    Patients

    Seq Age Sex Outcome Treatment
    1