BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3870922 · Received June 12, 2014

    Report

    Report Number
    9611451-2014-00508
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 15, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V VENTED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A BREAK IN THE WATER FEEDSET TUBE AT THE CONNECTION TO THE CHAMBER DOME. THE SURFACE OF THE BREAK WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130806. CONCLUSION: THE DAMAGE OBSERVED ON THE RETURNED MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS MOST LIKELY CAUSED BY THE FEEDSET TUBE BEING PULLED AWAY FROM THE CHAMBER, POSSIBLY DUE TO THE FEEDSET TUBE BEING CAUGHT OR UNDER TENSION. WE HAVE CONDUCTED EXTENSIVE TESTING OF THE MR290 CHAMBER, WITH PARTICULAR EMPHASIS ON FEEDSET BREAKS. SIGNIFICANTLY WE HAVE NOT BEEN ABLE TO REPLICATE FAILURE OF THE FEEDSET TUBE AT THE CHAMBER DOME IN ANY OF OUR TESTING. THE SPECIFICATION FOR THE CHAMBER REQUIRES THAT THE FEEDSET TUBE SHOULD HAVE A BREAKING STRAIN OF (B)(4). DURING PRODUCTION, PULL TESTING OF THE FEEDSET STRENGTH AT BOTH SPIKE AND DOME END IS PERFORMED (B)(4) ON MR290 CHAMBERS FROM EACH PRODUCTION LINE. ANY CHAMBER THAT FAILS IS REJECTED AND THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. ANY CHAMBER THAT FAILS IS REJECTED. THIS SUGGESTS THAT THE DAMAGE TO THE FEEDSET TUBE OCCURRED AFTER THE CHAMBER WAS RELEASED FOR DISTRIBUTION. THE 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS LEAKING. THEY FURTHER REPORTED DAMAGE TO THE WATER FEEDSET TUBE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347210 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1308060105

    Patients

    Seq Age Sex Outcome Treatment
    1 RT226 INFANT LOW FLOW BREATHING CIRCUIT