BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2851774 · Received November 29, 2012

    Report

    Report Number
    9611451-2012-00774
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 27, 2012
    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). PLEASE NOTE AN INITIAL REPORT WAS SUBMITTED ON (B)(4) 2012 WITH A FOLLOW UP DUE UPON COMPLETION OF OUR INVESTIGATION. DUE TO AN ERROR THE INITIAL REPORT WAS SUBMITTED VIA THE (B)(4). PLEASE CONSIDER THIS OUR INITIAL/FINAL REPORT FOR THIS COMPLAINT. RETURNED DEVICES: DEVICE 1-3 : LOT NUMBER 1110206, DEVICE 4: LOT NUMBER 120413. METHOD: FOUR COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. DEVICE 2 AND 3 WERE RETURNED IN AN UNSEALED BAG AND WERE VISUALLY INSPECTED FOR THE REPORTED DAMAGE. DEVICE 1 AND 4 ARRIVED SEALED AND WERE NOT INSPECTED IN THIS INVESTIGATION. RESULTS: VISUAL INSPECTION REVEALED THAT THERE WAS A BREAK IN THE FEEDSET TUBING AT THE CONNECTION TO THE CHAMBER DOME ON BOTH CHAMBERS. THE SURFACE AT THE BREAK WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 120413. CONCLUSION: THE DAMAGE APPEARS TO BE CAUSED BY THE TUBE BEING PULLED AWAY FROM THE CHAMBER, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE. ANY HOLES, LEAKS OR BREAKS 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 OUR DISTRIBUTOR THAT THE WATER FEEDSET TUBE OF FOUR MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 111026

    Patients

    Seq Age Sex Outcome Treatment
    1