BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2212409 · Received August 15, 2011

    Report

    Report Number
    9611451-2011-00491
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    July 22, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATES: 100303 - 03/03/2010; 101126 - 11/26/2010. THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVED THE COMPLAINT DEVICES AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATES: 100303 - 03/03/2010; 101126 - 11/26/2010. MANUFACTURER NARRATIVE METHOD: THE TWO COMPLAINT MR290V CHAMBERS WERE RETURNED TO FPH (B)(4) FOR INSPECTION. THE CHAMBERS WERE VISUALLY INSPECTED FOR DAMAGE AND WERE CONNECTED TO A WATERBAG FOR FUNCTIONAL TESTING. RESULTS: BOTH CHAMBERS FILLED NORMALLY WHEN CONNECTED TO A WATERBAG. ONCE THE CHAMBER WITH LOT NUMBER 100303 HAD FILLED, SMALL DROPS OF WATER WERE OBSERVED TO LEAK FROM THE CONNECTION BETWEEN THE FEEDSET TUBE AND WATERBAG SPIKE. INSPECTION SHOWED THAT INSUFFICIENT GLUE HAD BEEN APPLIED BETWEEN THE CONNECTION OF THE FEEDSET TUBE AND SPIKE, CAUSING THE LEAK. NO FAULT WAS FOUND WITH THE OTHER CHAMBER. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 100303. CONCLUSION: ALL CHAMBERS ARE PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARMS." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." THE WATERFEED TUBING IS ATTACHED TO THE SPIKE BY AN AUTOMATED GLUING PROCESS. AS PART OF OUR ONGOING IMPROVEMENT PROCESS, ADDITIONAL GLUE IS NOW APPLIED TO THE WATER FEEDSET SPIKE DURING THE AUTOMATED ASSEMBLY. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER LEAKED FROM THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND SPIKE OF TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS. THIS WAS NOTICED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER LEAKED FROM THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND SPIKE OF TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS. THIS WAS NOTICED DURING USE. 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 100303, 101126

    Patients

    Seq Age Sex Outcome Treatment
    1