BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3457079 · Received November 7, 2013

    Report

    Report Number
    9611451-2013-00889
    Event Type
    Malfunction
    Date Received
    November 7, 2013
    Date of Event
    October 8, 2013
    Report Date
    October 11, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE TWO COMPLAINT MR290 CHAMBERS WERE RECEIVED AND WERE VISUALLY INSPECTED FOR THE REPORTED DAMAGE. ONE CHAMBER WAS FROM LOT 130617 (MANUFACTURED 17 JUNE 2013) AND THE OTHER CHAMBER WAS FROM LOT 120229 (MANUFACTURED 29 FEB 2012). RESULTS: IN BOTH CHAMBERS VISUAL INSPECTION REVEALED A BREAK IN THE FEEDSET TUBE AT THE CONNECTION TO THE CHAMBER DOME. THE SURFACE OF THE BREAK WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR EITHER LOT NUMBER. CONCLUSION: THE DAMAGE TO THE RETURNED MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS 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 30 NEWTONS. DURING PRODUCTION, PULL TESTING OF THE FEEDSET STRENGTH AT BOTH SPIKE AND DOME END IS PERFORMED EVERY HOUR 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 CHAMBERS WERE 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 THE FEEDSETS OF TWO MR290 HUMIDIFICATION CHAMBERS WERE DAMAGED AND LEAKING WATER. THIS WAS FOUND BEFORE PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE FEEDSETS OF TWO MR290 HUMIDIFICATION CHAMBERS WERE DAMAGED AND LEAKING WATER. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574604 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 130617

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL RT329 BREATHING CIRCUIT| FISHER & PAYKEL RT329 BREATHING CIRCUIT| FISHER & PAYKEL RT340 BREATHING CIRCUIT