BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2591112 · Received May 29, 2012

    Report

    Report Number
    9611451-2012-00344
    Event Type
    Malfunction
    Date Received
    May 29, 2012
    Date of Event
    April 20, 2012
    Report Date
    May 2, 2012
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THREE MR290V CHAMBERS WERE RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE RETURNED CHAMBERS WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THERE WAS A BREAK IN THE FEEDSET TUBINGS OF THE RETURNED CHAMBERS. THE BREAK WAS LOCATED AT THE CONNECTION TO THE WATER BAG SPIKE. THE SURFACE OF THE BREAK WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110914. CONCLUSION: THE DAMAGE APPEARED TO BE CAUSED BY THE TUBE BEING PULLED AWAY FROM THE SPIKE, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THIS SUGGESTS THAT THE DAMAGE OCCURRED POST PRODUCTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARM." "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 THREE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS EACH HAD A WATER LEAK BETWEEN THE CONNECTION OF THE WATER FEEDSET TUBE AND SPIKE. THIS WAS NOTICED DURING 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 110914

    Patients

    Seq Age Sex Outcome Treatment
    1