BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3380194 · Received October 1, 2013

    Report

    Report Number
    9611451-2013-00744
    Event Type
    Malfunction
    Date Received
    October 1, 2013
    Date of Event
    September 1, 2013
    Report Date
    September 3, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).LOT NUMBER MANUFACTURING DATE QUANTITY AFFECTED110923 09/23/2011 2 110926 09/26/2011 1THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE DESTROYED AT THE HOSPITAL FACILITY. THE INFORMATION PROVIDED BY THE HOSPITAL WAS NOT SUFFICIENT TO DETERMINE WHAT HAD CAUSED THE REPORTED LEAK. WITHOUT THE COMPLAINT DEVICES WE ARE UNABLE TO CONFIRM OR CONCLUDE THE ROOT CAUSE OF THE REPORTED FAULT. 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. 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. CHAMBERS THAT FAIL ANY OF THESE TESTS ARE DISCARDED. THIS SUGGESTS THAT THE DAMAGE OCCURRED AFTER THE SUBJECT MR290 WAS RELEASED FOR DISTRIBUTION. 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." DEVICES WERE DESTROYED AT THE HOSPITAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A DISTRIBUTOR THAT THE WATER FEEDSET TUBES OF THREE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND LEAKING DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED. IT WAS FURTHER REPORTED THAT THE COMPLAINT DEVICES WERE DESTROYED AT THE HOSPITAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495210 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 110923 AND 110926

    Patients

    Seq Age Sex Outcome Treatment
    1 RT225 INFANT BIAS FLOW BREATHING CIRCUIT