BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2018584 · Received March 14, 2011

    Report

    Report Number
    9611451-2011-00156
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 14, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 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 VENTED HUMIDIFICATION CHAMBER WAS PERFORMANCE TESTED BY CONNECTING TO A WATERBAG. IT WAS ALSO VISUALLY INSPECTED FOR DAMAGE. RESULTS: WHEN THE CHAMBER WAS CONNECTED TO THE WATERBAG, NO WATER FLOWED THROUGH THE FEEDSET TUBING, CONFIRMING THE REPORTED FAULT. VISUAL INSPECTION REVEALED THAT THERE WAS AN OCCLUSION BELOW THE CONNECTION BETWEEN THE WATER FEEDSET AND THE CHAMBER DOME. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100907. CONCLUSION: BLOCKAGE IN THE VALVE SYSTEM OF THE RETURNED CHAMBER PREVENTED THE WATER FROM FLOWING THROUGH. ALL CHAMBERS ARE TESTED PRIOR TO LEAVING THE PRODUCTION LINE, ENSURING THAT THERE IS SUFFICIENT FLOW THROUGH THE FEEDSET AND INTO THE CHAMBER. IT IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. AS THE SUBJECT CHAMBER WORKED PROPERLY FOR THREE DAYS, THIS SUGGESTS THAT THE BLOCKAGE DEVELOPED POST PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) PRODUCT SPECIALIST THAT THE "WATER WAS NOT SUPPLIED" TO THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER AFTER THREE DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) PRODUCT SPECIALIST THAT THE "WATER WAS NOT SUPPLIED" TO THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER AFTER THREE DAYS OF 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 100907

    Patients

    Seq Age Sex Outcome Treatment
    1