BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 4003773 · Received August 12, 2014

    Report

    Report Number
    9611451-2014-00703
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 30, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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: THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: INSPECTION OF THE COMPLAINT FEEDSET TUBE AND CHAMBER DOME REVEALED THAT THERE WAS SUFFICIENT GLUE ON THE FEEDSET TUBE BUT THE GLUE WAS ONLY PARTLY BONDING. THE FEEDSET TUBE WAS FOUND TO BE SLIGHTLY PULLED OUT OF THE CHAMBER DOME. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT 130806. CONCLUSION: WE WERE UNABLE TO DEFINITIVELY DETERMINE THE CAUSE OF THE FEEDSET BREAK, HOWEVER OUR PREVIOUS INVESTIGATIONS INTO SIMILAR COMPLAINTS HAVE SHOWN THAT THIS DAMAGE CAN BE CAUSED BY THE OVERSTRETCHING OF THE TUBING WHEN ATTACHING IT TO A WATER BAG. 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 OR WATER BAG SPIKE 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. IF ANY FAULTS ARE DETECTED THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. ADDITIONALLY 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 PROBLEM OCCURRED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER 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 A DISTRIBUTOR THAT WATER LEAKED AT THE CONNECTION BETWEEN THE CHAMBER DOME AND WATER FEEDSET TUBE OF AN MR290 HUMIDIFICATION CHAMBER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477970 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 130806

    Patients

    Seq Age Sex Outcome Treatment
    1